Insulin Glargine

Change in HbA1c at month 6

HbA1c

Composite outcome

The change in HbA1c from baseline to week 26

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

Time to Anion Gap Closure

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 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

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

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

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

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

HbA1c

HbA1c

HbA1c, FBG

Percentage of participants with Treatment Emergent Adverse Events (TEAEs)

Intergroup remission rate at 24 week

Number Of Hypoglycemic events

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

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

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

ß-cell Function parameter

Intrahepatic lipids (IHL)

To evaluate the treatment efficacy

mean amplitude of glycemic excursions( MAGE)

Number of Participants With Stress Hyperglycemic Events in the Intensive Care Unit (ICU)

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

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

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%

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

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

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

Change in HbA1c From Baseline to Week 30

Change in HbA1c From Baseline

Absolute change from baseline in HbA1c

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 From Baseline in Glycosylated Hemoglobin (HbA1c) at 26 Weeks

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 HbA1c from baseline

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

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 Glycosylated Haemoglobin (HbA1c)

Change in HbA1c

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

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

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

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

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

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

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.

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.

Beta-cell Function After 52 Weeks of Therapy

Blood Glucose Area Under the Curve (AUC)

Final angiogenesis

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

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)

HbA1c

Change in fasting plasma glucose (FPG)

AUCISEC(0-10min)

To compare the maximal post prandial blood glucose concentration and the time to maximal post prandial glucose concentration between the different treatments

PK endpoint

Change in flow mediated dilation

Number of adverse events (AEs)

Number of treatment-emergent adverse events

Incidence of adverse events

Area under the glucose infusion rate curve

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

Number of treatment-emergent adverse events (AEs)

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

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

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

The incidence of diabetic retinopathy

Lower beta hydroxybutyrate levels