Insulin Glargine

Change in HbA1c at month 6

HbA1c >= 6.5%

Time in range (TIR, 70-180 mg/dL)

HbA1c

Composite outcome

The change in HbA1c from baseline to week 26

Total and Domain Specific Score of the mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients

24-hour CGM Time Above Range (TAR) >180 mg/dL (%) - averaged over Day 1-9

food-stimuli related neuronal activity in reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%)

HbA1c

Treatment satisfaction

AUC GIR(0-t)

Insulin Sensitivity

Percentage of Participants With Individualized Glycated Hemoglobin Target Attainment Per Healthcare Effectiveness Data and Information Set (HEDIS) Criteria Without Documented Symptomatic(Blood Glucose <=70 mg/dL [<=3.9 mmol/L]) and/or Severe Hypoglycemia

Main study: Frequency of severe hypoglycaemia

INITIATION: 24-Week Endpoint Glycosylated Hemoglobin (HbA1c)

The percentage of patients with a 3-step or greater progression in the patient

Percentage of patients with HbA1c <7% achievement

Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no documented symptomatic hypoglycemia (confirmed by a Plasma Glucose (PG) ≤ 56 mg/dL [3.1 mmol/L]

Change in HbA1c (percentage %)

Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - Intent To Treat (ITT) Population Without Good Clinical Practices (GCP) Noncompliant Sites)

Mean change in HbA1c from baseline to week 24

Change (decrease) in mean hemoglobin glycosylated (HbA1c) level

Change in Glycosylated Haemoglobin (HbA1c)

Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)

Glycosylated Haemoglobin A1c (HbA1c)

Hypoglycaemic events (severe, symptomatic, asymptomatic, nocturnal) before, during and after Ramadan

Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 26 for the Per Protocol (PP) Population

Change in Haemoglobin A1c (HbA1c) From Baseline to 24 Week Endpoint

Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery

Time-in-serious Hypoglycemia

Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12

Percentage of subjects achieving HbA1c < 7% at the end of the study.

A1c values

Change in hemoglobin A1c (HbA1c)

Health Assessment, Patient treatment satisfaction and Quality-of-Life

Percentage of Time of Glucose Concentration Within the Target Range of Greater Than or Equal to (>=) 70 to Less Than or Equal to (<=) 180 Milligrams Per Deciliter: Non-inferiority Analysis

Wound Healing

HbA1C

Oxidative stress markers with the new slow insulin analogues

% of responders with HbA1c<7% and/or a final decrease of HbA1c>15% compare to the basal value (HbA1c final - HbA1c basal).

HbA1c

HbA1c

HbA1c, FBG

Mean Blood Glucose Concentration

Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

Changes in Hemoglobin A1c (HbA1c) level

Intergroup remission rate at 24 week

Change in HbA1c level for patients with addition of glulisine at week 12

Change in hemoglobin A1c (HbA1c) values (following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC))

Mean and median HbA1c (% and mmol/mol)

Number Of Hypoglycemic events

Percentage of Participants Achieving and Maintaining Individualized Glycated Hemoglobin A1c (HbA1c) Targets Without Clinically Significant Hypoglycemia

the proportion of patients with HbA1c < 7.0% without experiencing hypoglycemia and without weight gain,with a superiority margin of 3%

Number of Participants Achieving Drug-free Diabetes Remission in the Experimental Group Compared to the Control Group

Percentage of Participants With at Least 1 Documented Hypoglycemic Event With Blood Glucose <54 Milligrams Per Deciliter (mg/dL)

Superiority is based on observing clinically significant difference in glycaemic control (> than or = to 0,5 % HbA1c). Programs are defined as equally successful if the HbA1c differs less than 0,5 %.

Change From Baseline to Week 16 in the Percentage of Time in Range [70 to 180 Milligram Per Deciliter (mg/dL)]

Time in range at week 13

The change in blood glucose variability

The Percentage of Patients Achieving HbA1c <=7% at Week 24 With no Gain in Body Weight From Baseline and no Incidence of Severe Hypoglycemia

Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)

Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline

Change in hemoglobin A1c (HbA1c) level from baseline to end point for each treatment group.

Percentage of patients achieving HbA1c level < 8% (in patients 6-12 year-old) and HbA1c level < 7.5 % (in patients 13-17 year-old)

Evaluating the Glycemic control of the regimen : Change in A1C levels

Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.

Number of Participants Experiencing Stress Hyperglycemia

Change in liver fat content（%） measured by MRS

Intrahepatic lipids (IHL)

ß-cell Function parameter

Mean blood glucose

To evaluate the treatment efficacy

mean amplitude of glycemic excursions( MAGE)

Mean change in Glycosylated haemoglobin (HbA1c)

HbA1C

Compare twice-daily insulin lispro Low Mix therapy and once-daily insulin glargine therapy with respect to perceived mood on patient-rated questionnaires following chronic treatment administration in patients with type 2 diabetes

Primary efficacy data was HbA1c.

The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise

Reduction of restenosis after peripheral angioplasty

Mean amplitude of glycemic excursions (MAGE) change from baseline by continuous glucose monitoring system (CGMS)

Effect of pioglitazone vs. insulin glargine on beta-cell function and insulin sensitivity

3 days continual glycaemic profile fluctuation

Glucose excursion (which, as defined below, is the change in blood glucose between the start and finish of one hour of exercise)

The percentage of patients achieving glycosylated haemoglobin (HbA1c) levels < or = 7.0%

Compare % of subjects with glucose > or = to 56 mg/dL at any point of 8-point glucose profiles during 3 consecutive days

Change From Baseline in Glycated Hemoglobin A1c (HbA1c) to Week 24

Glycaemic parameters assessment

effect of insulin treatment on myocardial function, perfusion and glucose metabolism.

Area under GIR-curve, maximal glucose infusion rate, time to maximal glucose infusion rate.

Mean difference in HbA1c (efficacy)

Change in Hepatic Lipid Content From Baseline Visit to Six Month Follow up Visit

Brain insulin sensitivity

Composite of the First Occurrence of Cardiovascular (CV) Death, Nonfatal Myocardial Infarction (MI) or Nonfatal Stroke

Time From Randomisation to First Occurrence of a Major Adverse Cardiovascular Event (MACE): Cardiovascular Death, Non-fatal Myocardial Infarction, or Non-fatal Stroke

Non-inferiority of zenagamtide versus insulin glargine: change in haemoglobin A1c (HbA1c)

Change From Baseline in Hemoglobin A1c (HbA1c) at 26 Weeks

Change From Baseline in A1C at Week 26: Excluding Rescue Approach

Change in HbA1c From Baseline to Week 30

Change in HbA1c From Baseline

Absolute change from baseline in HbA1c

Change in HbA1c From Baseline to Week 26

Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification

Mean Change From Baseline in Hemoglobin A1c (HbA1c) (10 mg and 15 mg)

Change in HbA1c From Baseline to Month 6 Endpoint

Change in HbA1c From Baseline to Month 6 Endpoint

Change From Baseline to 52 Weeks Endpoint in Glycosylated Hemoglobin (HbA1c)

Change in HbA1c From Baseline to Month 6 Endpoint

Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)

Change From Baseline in Hemoglobin A1c (HbA1c) Efficacy Estimand at Week 26

Change From Baseline in Hemoglobin A1C at Week 54

Change From Baseline in A1C at Week 30

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period

Change in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c

Change From Baseline in Hemoglobin A1c (HbA1c)

Change in HbA1c from baseline

HbA1c

Change in HbA1c From Baseline to Week 24: Non-Inferiority Analysis

Change in HbA1c

Change in total glycated hemoglobin measured as HbA1c equivalents (GHb )from baseline to endpoint

Treatment-induced Anti-Insulin Antibody (TI-AIA) is the Primary Endpoint

Change in HbA1c From Baseline to 24 Weeks

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.

Change from Baseline in HbA1c at Week 26

Change From Baseline up to 24 Weeks in Hemoglobin A1c (HbA1c)

Change From Baseline in Participant Hemoglobin A1C Level at Week 24

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment

Change from baseline in HbA1c

Change From Baseline in Glycated Hemoglobin (HbA1c) to Week 26: Core Period

Change in HbA1c From Baseline to Week 26

Change in HbA1c (Glycosylated Haemoglobin)

Change in HbA1c From Baseline to Week 26

Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period

To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.

Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)

Change in Glycosylated Haemoglobin (HbA1c)

Change in HbA1c

Change in HbA1c

Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 %

Change From Baseline in Hemoglobin A1c (HbA1c) to Week 24

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

Change From Baseline in Hemoglobin A1C (HbA1c) at Endpoint (Last Observation Carried Forward [LOCF])

HbA1c

HbA1c

HbA1c

Change From Baseline to 28 Weeks in Hemoglobin A1c (HbA1c)

Change in Glycosylated Haemoglobin (HbA1c)

Change From Baseline in Hemoglobin A1c (HbA1c)

Compare the change in glycemic control (as measured by A1c) from baseline to endpoint of fixed dose bolus regimen vs. variable bolus regimen based on carbohydrate count

Hemoglobin A1c less than 7%

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26

Change from baseline in HbA1c

To determine the difference in glycemic control as measured by HbA1C between substituting the TZD with insulin glargine and adding a third oral agent in patients who fail a TZD/sulfonylurea or TZD/metformin combination therapy

Change from baseline in hemoglobin A1c (HbA1c) levels at week 24

Absolute change of glycosylated hemoglobin (HbA1c)

Hypoglycemia

Percentage of patients reaching fasting SMPG target range 90-130 mg/dL (5.0-7.2 mmol/L) at Week 16 (mean of the last 5 readings recorded over the last 2 weeks) without a severe hypoglycemic episode during the 16-week on-treatment period

Change From Baseline (Visit 18) in Glycosylated Haemoglobin (HbA1c) at the End of Each 16 Week Treatment Period

Compare, in insulin-naive patients with type 2 diabetes on one or more oral antihyperglycemic medications, a regimen adding mealtime HIIP versus a regimen adding insulin glargine with respect to change in HbA1c from baseline to endpoint.

Change From Baseline in HbA1c to Week 16

Event Rate of "All Hypoglycemia" Defined as the Total Number of Episodes Divided by the Total Duration of the On-treatment Period in Years (Events Per Patient-year)

HbA1c Response Rate: Percentage of Patients Achieving Glycosylated Haemoglobin A1c (HbA1c) < 7% at Study Endpoint (End of Treatment Period)

To evaluate safety & efficacy of Insulin glargine ( injection at bedtime, once a day) on the changes of HbA1c.

Compare efficacy of insulin glargine & short acting insulin (Lispro), NPH insulin regime as basal insulin and regular insulin for meal insulin for metabolic control, evaluated by means of HbA1c .

Mean Change From Baseline in HbA1c

Beta-cell Function After 52 Weeks of Therapy

To describe changes in hepatic fat content between groups.

1-Year Overall Survival Rate

Infarct Size Absolute Change From Baseline at Day 60

Blood Glucose Area Under the Curve (AUC)

Mean Plasma Glucose (MPG) Throughout Hospital Study Period

Final angiogenesis

Change in HbA1c From Baseline to Week 24

Fasting Blood Glucose (FBG) Level at Week 12 Endpoint as Measured by the 8-Point Self-Monitored Blood Glucose (SMBG) Profiles

Percentage of Time in Target Range (TIR) 3.9-10.0 Millimoles Per Liter (mmol/L) (70-180 Milligrams Per Deciliter (mg/dL) Measured Using CGM (Continuous Glucose Monitoring)

Change in Glycosylated Haemoglobin (HbA1c)

Percentage of Time in Target Range 3.9-10.0 mmol/L (70-180 Milligrams Per Deciliter (mg/dL)) Measured Using CGM (Continuous Glucose Monitoring)

Change From Baseline in Glycosylated Hemoglobin A1C (HbA1c) at the End of Each Treatment Period

HbA1c

the rates of rebound hyperglycemia

Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL])

Change in fasting plasma glucose (FPG)

AUCISEC(0-10min)

Does early administration of insulin glargine result in a change in ICU length of stay when compared to usual care for the treatment of diabetic ketoacidosis?

PK endpoint

Change in flow mediated dilation

Number of adverse events (AEs)

Number of adverse events

Number of treatment-emergent adverse events

Area under the glucose infusion rate curve

Incidence of adverse events

Area under the glucose infusion rate curve

Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) of Insulin Glargine and Lantus

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Area under the glucose infusion rate curve during one dosing interval at steady state

Area under the serum insulin concentration curve within 24 hours (INS-AUC0-24) after dosing on Day 6

the unadjusted 6-hour postprandial blood glucose excursion (AUCBG0-6h) following ingestion of a standardized breakfast

Area under the glucose infusion rate curve

BGpre-exe - BGminimum,exe, difference between blood glucose concentration before exercise and the minimum blood glucose concentration observed during exercise

Area under the NN1250 concentration-time curve after single dose

Number of treatment-emergent adverse events (AEs)

Delta AUC BG 0-2h (area under the blood glucose concentration-time curve)

Area under the insulin concentration curve (AUC)

Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

AUCGIR 0-6h

Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro

Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration

AUCGIR 0-2h

Area under the glucose infusion rate curve (AUCGIR) 12-30h (mg/kg)

Pharmacokinetics: Area Under the Serum LY2963016 or Lantus Concentration-Time Curve (AUC) From Zero to Infinity [AUC(0-∞)]

Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)

Variation in morning FPG

Pharmacodynamics: Duration of Action of LY2963016 and Lantus

Maximum Glucose Infusion Rate

Efficacy: 8-point blood glucose measurements.

Very Low Density Lipoprotein-Triglyceride (VLDL-TG) Concentrations

The incidence of diabetic retinopathy

Lower beta hydroxybutyrate levels