Insulin Glargine Combination Therapies in Type II Diabetics (LAPTOP)
This study has been completed.
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00783744
First received: October 31, 2008
Last updated: September 25, 2009
Last verified: September 2009
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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:
Drug Information available for:
Metformin
Metformin hydrochloride
Insulin, NPH
Insulin human
Insulin, isophane
Glimepiride
Insulin glargine
U.S. FDA Resources
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
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 Glimepiride Glargine Insulin Hypoglycemic Agents Insulin, NPH |
Metformin Insulin, Long-Acting Physiological Effects of Drugs Pharmacologic Actions Immunosuppressive Agents Immunologic Factors Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013