Insulin Glargine Combination Therapies in Type II Diabetics (LAPTOP)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783744
First received: October 31, 2008
Last updated: September 25, 2009
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: Glimepiride
Drug: Metformin
Drug: Insulin monotherapy with premixed insulin NPH 30/70
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Frequency of subjects with HbA1c ≤ 7.0 % and > 7.0 % [ Time Frame: At endpoint ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change of fasting blood glucose [ Time Frame: baseline to endpoint ] [ Designated as safety issue: No ]
  • Change of nocturnal & mean daytime blood glucose [ Time Frame: baseline to endpoint ] [ Designated as safety issue: No ]
  • Change of fasting plasma glucose [ Time Frame: baseline to endpoint and all visits ] [ Designated as safety issue: No ]
  • Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) [ Time Frame: Baseline to endpoint ] [ Designated as safety issue: No ]
  • 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) [ Time Frame: At endpoint ] [ Designated as safety issue: No ]

Enrollment: 375
Study Start Date: December 2001
Primary Completion Date: August 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Insulin Glargine + Glimepiride + Metformin
Drug: Insulin Glargine
In the morning to target FBG ≤ 100 mg/dl
Drug: Glimepiride
Glimepiride 3 or 4 mg
Drug: Metformin
At least 850 mg od
Active Comparator: 2
Insulin monotherapy with premixed insulin NPH 30/70
Drug: Insulin monotherapy with premixed insulin NPH 30/70
Given before breakfast and before dinner, target of pre-prandial BG ≤ 100 mg/dl

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00783744

Locations
Austria
Sanofi aventis administrative office
Vienna, Austria
Finland
Sanofi-aventis administrative office
Helsinki, Finland
France
Sanofi-aventis administrative office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milan, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
United Kingdom
Sanofi-Aventis Administrative Office
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Christine Kliebe-Frisch, MD Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00783744     History of Changes
Other Study ID Numbers: HOE901_4027
Study First Received: October 31, 2008
Last Updated: September 25, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Glimepiride
Glargine
Insulin
Hypoglycemic Agents
Insulin, Isophane
Metformin
Insulin, Long-Acting
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 28, 2014