Insulin Glargine "All to Target" Trial

Phase 4

Completed

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Premixed Insulin
Drug: Insulin Glargine
Drug: Insulin Glulisine

Registration Number: NCT00384085

Lead Sponsor: Sanofi

Brief Summary: The primary objectives were:

* To demonstrate the superiority of Lantus plus stepwise addition of mealtime Apidra® (Lantus/Apidra-3) versus twice-daily Premixed insulin based on the proportion of patients achieving target glycemic control (as measured by hemoglobin A1c \[HbA1c\] \<7.0%) at Week 60

* To demonstrate the noninferiority of Lantus plus addition of 1 mealtime Apidra injection (Lantus/Apidra-1) versus twice-daily Premixed insulin based on the reduction from Baseline to Week 60 in HbA1c

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 588

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novolog Mix 70/30	Premixed Insulin	Premixed insulin (Novolog® Mix 70/30) added to oral agents.
Lantus/Apidra-3	Insulin Glargine	Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Lantus/Apidra-1	Insulin Glulisine	Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
Lantus/Apidra-3	Insulin Glulisine	Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
Lantus/Apidra-1	Insulin Glargine	Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.

Primary Outcome Measures

Name	Time	Method
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)	At week 60	Responders defined as patients who achieved an HbA1c value \<7.0% versus nonresponders. Patients who did not achieve an HbA1c value \<7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.
Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)Per Protocol Population	At week 60	Absolute Change in HbA1c from Baseline to Week 60. If the Week 60 HbA1c evaluation was missing, the patient was counted as having not completed per protocol.
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) < 7.0% at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30 - ITT Population With All Sites) (Sensitivity Analysis)	At week 60	Responders defined as patients who achieved an HbA1c value \<7.0% versus nonresponders. Patients who did not achieve an HbA1c value \<7.0% and patients with a missing HbA1c value at Week 60 were considered to be nonresponders.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Glycosylated Hemoglobin A1c (HbA1c) at Week 60 (Lantus/Apidra-3 Versus Novolog Mix 70/30)	From baseline to week 60	Absolute Change in HbA1c from Baseline to Week 60.
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 (Lantus/Apidra-1 Versus Novolog Mix 70/30)	At week 60	Patients who achieved an HbA1c value \<7.0% were defined as responders. Patients who did not achieve HbA1c values \<7.0% and patients with missing HbA1c values were considered nonresponders.
Percentage of Patients Achieving Glycosylated Hemoglobin A1c (HbA1c) <7.0% at Week 60 Without a Severe Hypoglycemic Event or a Symptomatic Hypoglycemic Event With an Self Monitoring Blood Glucose (SMBG) <50 mg/dl	At week 60	Severe hypoglycemia was defined as an event with clinical symptoms that are considered to result from hypoglycemia in which the patient required assistance of another person and one of the following: the event was associated with a measured blood glucose level below 36 mg/dL or the event was associated with prompt recovery after oral carbohydrate, iv glucose, or glucagon administration. A symptomatic hypoglycemic event was defined as a hypoglycemic episode with an associated SMBG value of \<50 mg/dL with reported symptoms.
Adjusted Incidence Rate of Hypoglycemia	Week 60	Adjusted incidence rate of hypoglycemia: estimated percent of patients having at least 1 event of a given type of hypoglycemia. A severe Hypoglycemic Event (HE) is one where patient requires assistance. It is confirmed either by a prompt response to certain countermeasures or by a blood Glucose (BG) \<36 mg/dL during or soon after the event. A serious HE is one where the patient has loss of consciousness, coma, seizure, or convulsion. Nocturnal = events occurring between 00:00 \& 06:00 based on a 24-hour clock. An event is included if the HE start date is within the treatment period.
Adjusted Hypoglycemic Event Rates (Event/Patient-year)	Week 60	Adjusted Hypoglycemic event rate: Total # of events for a given type of hypoglycemia divided by the total exposure to study drug (patient-years). Rates are estimated from a general linear model adjusted for baseline BMI and oral agent combination of antidiabetic medications on which the patient entered the study. An event is included if the hypoglycemic event start date is within the treatment period (i.e., from the Randomization date to \& including 1 day after the date of last dose of study drug).