Insulin Glulisine in Type 2 Diabetic Patients (Basal Plus)

Comparison of Two Therapeutic Strategies for Treating Type 2 Diabetic Patients Poorly Controlled With Basal Insulin Associated With Oral Antidiabetic Drugs : 6-month Proof of Concept Study.

To evaluate the efficacy of a single injection of glulisine before the main meal added to insulin glargine plus oral antidiabetic drugs (OADs) compared to insulin glargine plus OADs in Type 2 diabetic patients poorly controlled with basal insulin plus OADs.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Insulin Glulisine; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 4

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Sanofi-Aventis
• United Kingdom
  • Guildford, United Kingdom
    • Sanofi-Aventis
• United States
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diabetes Mellitus, Type 2
• 25 < BMI < 45 kg/m²
• 7,5% < HbA1c < 9%
• Treated with a basal insulin (NPH, Insulin Zinc, Insulin glargine or Insulin detemir), and at least 1g metformin daily, for more than 3 months

Exclusion Criteria:

• Type 1 diabetes mellitus
• Treatment with OADs only
• Treatment with thiazolidinediones, with exenatide or with pramlintide
• Treatment with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue)
• Active proliferative diabetic retinopathy,
• Pregnancy (women of childbearing potential must have a negative pregnancy test at study entry and effective contraception)
• Breast-feeding
• History of hypersensitivity to the study drugs or to drugs with a similar chemical structure.
• Treatment with systemic corticosteroids in the 3 months prior to study entry
• Treatment with any investigational product in the 2 months prior to study entry
• Previous treatment with insulin glulisine
• Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
• Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major disease making implementation of the protocol or interpretation of the study results difficult
• Impaired hepatic function
• Impaired renal function
• History of drug or alcohol abuse

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: insulin glulisine+insulin glargine+metformin+glimepiride; Bolus arm	Drug: Insulin Glargine; One daily injection at bedtime; Drug: Glimepiride; At same dosage as during the run-in period; Drug: Insulin Glulisine; One bolus given before the main meal; Drug: Metformin; At same dosage as during the run-in period
Other: insulin glargine+metformin+glimepiride; Control arm	Drug: Insulin Glargine; One daily injection at bedtime; Drug: Glimepiride; At same dosage as during the run-in period; Drug: Metformin; At same dosage as during the run-in period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%	Glycosylated Haemoglobin (HbA1c) is a biological parameter that reflects the blood glucose concentration over a long period of time. It is the standard parameter for glycemic control follow -up in diabetic patients. this parameter is expressed in percentage (%) and the target in diabetes management is to reach a HbA1c <7%	at the end of treatment (week 24)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycosylated Haemoglobin (HbA1c) Value		at the end of treatment (week 24)
Change in Glycosylated Haemoglobin (HbA1c) Value		from baseline to the end of treatment (week 24)
Daily Mean Plasma Glucose		at the end of treatment (week 24)
Change in Daily Mean Plasma Glucose		from baseline to the end of treatment (week 24)
Change in Weight		from baseline to the end of treatment (week 24)
Daily Dose of Insulin Glargine	Mean of 3 daily doses reported during the week prior to the final visit	at the end of treatment (week 24)
Daily Dose of Insulin Glulisine	Mean of 3 daily doses reported during the week prior to the final visit	at the end of treatment (week 24)
Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL		during treatment period (12 weeks)
Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL		during treatment period (12 weeks)
Rate of Severe Symptomatic Hypoglycemia		during treatment period (12 weeks)

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: PILORGET Valérie, MD, Sanofi

Study record dates

Study Major Dates

• Study Start: July 1, 2006
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: August 3, 2006
• First Submitted That Met QC Criteria: August 4, 2006
• First Posted (Estimate): August 7, 2006

Study Record Updates

• Last Update Posted (Estimate): August 8, 2011
• Last Update Submitted That Met QC Criteria: August 1, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Glimepiride; Insulin glulisine
• Other Study ID Numbers: HMR1964A_4002; EUDRACT # : 2005-002614-38