Insulin Glulisine in Type 2 Diabetic Patients

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Insulin Glargine; Drug: Glimepiride; Drug: Insulin Glulisine; Drug: Metformin

• Registration Number: NCT00360698
• Lead Sponsor: Sanofi

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-08-03
• Study First Submitted QC: 2006-08-04
• Study First Posted: 2006-08-07
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Results First Submitted: 2009-08-20
• Results First Submitted QC: 2009-10-27
• Results First Posted: 2009-12-02
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-01
• Last Update Posted: 2011-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
insulin glulisine+insulin glargine+metformin+glimepiride	Insulin Glulisine	Bolus arm
insulin glulisine+insulin glargine+metformin+glimepiride	Metformin	Bolus arm
insulin glargine+metformin+glimepiride	Insulin Glargine	Control arm
insulin glargine+metformin+glimepiride	Glimepiride	Control arm
insulin glargine+metformin+glimepiride	Metformin	Control arm
insulin glulisine+insulin glargine+metformin+glimepiride	Glimepiride	Bolus arm
insulin glulisine+insulin glargine+metformin+glimepiride	Insulin Glargine	Bolus arm

Primary Outcome Measures

Name	Time	Method
Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%	at the end of treatment (week 24)	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%

Secondary Outcome Measures

Name	Time	Method
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	at the end of treatment (week 24)	Mean of 3 daily doses reported during the week prior to the final visit
Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL	during treatment period (12 weeks)
Daily Dose of Insulin Glulisine	at the end of treatment (week 24)	Mean of 3 daily doses reported during the week prior to the final visit
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)

Trial Locations

Locations (2)

Sanofi-Aventis; 🇷🇺 Moscow, Russian Federation

Sanofi-aventis; 🇬🇧 Guildford, United Kingdom