Insulin Glargine Combination Therapies in Type II Diabetics

Diabetes Mellitus, Type 2 Clinical Trial

— LAPTOP  

Official title:

28-week, Open, Randomized, Multinational, Multicenter Clinical Trial to Compare Efficacy and Safety of Combination Therapy of Glimepiride Plus Metformin Plus HOE901 Insulin Analogue Versus a Two-injection Conventional Therapy With Premixed Insulin NPH 30/70 Bid in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Antidiabetic Drug Treatment.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783744
• Other study ID #: HOE901_4027
• Status: Completed
• Phase: Phase 3
• First received: October 31, 2008
• Last updated: September 25, 2009
• Start date: December 2001

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

To compare efficacy of combination therapy of insulin glargine plus glimepiride and metformin versus 2 injections insulin monotherapy with premixed insulin NPH 30/70 bid in terms of change of HbA1c (baseline to endpoint) to show non-inferiority of insulin glargine plus glimepiride and metformin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diabetes mellitus patients type 2, poorly controlled with oral antidiabetic drug treatment(glimepiride 3 or 4 mg od or any sulfonylurea similar to glimepiride 3 or 4 mg in combination with metformin in a dose at least similar to 850 mg once daily)

• HbA1c value = 7.5 % to = 10.5 %

• FBG = 120 mg/dl (6.6 mmol/l)

• BMI = 35 kg/m²

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
In the morning to target FBG = 100 mg/dl
• Glimepiride
Glimepiride 3 or 4 mg
• Metformin
At least 850 mg od
• Insulin monotherapy with premixed insulin NPH 30/70
Given before breakfast and before dinner, target of pre-prandial BG = 100 mg/dl

Locations

Country	Name	City	State
Austria	Sanofi aventis administrative office	Vienna
Finland	Sanofi-aventis administrative office	Helsinki
France	Sanofi-aventis administrative office	Paris
Germany	Sanofi-Aventis Administrative Office	Berlin
Italy	Sanofi-Aventis Administrative Office	Milan
Netherlands	Sanofi-Aventis Administrative Office	Gouda
Spain	Sanofi-Aventis Administrative Office	Barcelona
Sweden	Sanofi-Aventis Administrative Office	Bromma
Switzerland	Sanofi-Aventis Administrative Office	Geneva
United Kingdom	Sanofi-Aventis Administrative Office	Guildford

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Austria,  Finland,  France,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of subjects with HbA1c = 7.0 % and > 7.0 %		At endpoint	No
Secondary	Change of fasting blood glucose		baseline to endpoint	No
Secondary	Change of nocturnal & mean daytime blood glucose		baseline to endpoint	No
Secondary	Change of fasting plasma glucose		baseline to endpoint and all visits	No
Secondary	Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)		Baseline to endpoint	No
Secondary	Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic)		Baseline to endpoint	No
Secondary	Frequency of subjects with FBG = 100 mg/dl (5.5 mmol/l), 100 mg/dl < FBG = 120 mg/dl (5.5 mmol/l < FBG = 6.6 mmol/l), 120 mg/dl < FBG = 150 mg/dl (6.6 mmol/l < FBG = 8.3 mmol/l) and > 150 mg/dl (> 8.3 mmol/l)		At endpoint	No