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Insulin Glulisine in Type 2 Diabetic Patients | Clinical Trials | Clareo Health

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Insulin Glulisine in Type 2 Diabetic Patients

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.

NCT00360698•Sanofi

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (3)

Sanofi-aventis

Bridgewater, New Jersey, United States

Sanofi-Aventis

Moscow, Russia

Sanofi-aventis

Guildford, United Kingdom

Key Dates

Start Date

July 1, 2006

Primary Completion Date

August 1, 2008

Completion Date

August 1, 2008

Last Updated

August 8, 2011

Enrollment

106

ACTUAL participants

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine

DRUG

Glimepiride

DRUG

Insulin Glulisine

DRUG

Metformin

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 8, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Insulin Glulisine in Type 2 Diabetic Patients

Inclusion Criteria

Exclusion Criteria

PATHS-UP Health Behavior Self-monitoring Mobile App for Adolescents

Michigan Men's Diabetes Project III(MenDIII): Mind and Motion

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