Insulin Glulisine in Type 2 Diabetic Patients

NCT00360698 | Completed Phase 4 Results

• 2 other identifiers: HMR1964A_4002EUDRACT # : 2005-002614-38
• Study Type: interventional
• Target: 106
• Locations: 3 countries
• Sites: 3

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Patients With Glycosylated Haemoglobin (HbA1c) Value < 7%

  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%

  at the end of treatment (week 24)

Secondary Outcomes (10)

• 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)

Study Arms (2)

insulin glulisine+insulin glargine+metformin+glimepiride

OTHER

Bolus arm

Drug: Insulin Glargine; Drug: Glimepiride; Drug: Insulin Glulisine; Drug: Metformin

insulin glargine+metformin+glimepiride

OTHER

Control arm

Drug: Insulin Glargine; Drug: Glimepiride; Drug: Metformin

Interventions

Insulin Glargine DRUG

One daily injection at bedtime

insulin glargine+metformin+glimepiride; insulin glulisine+insulin glargine+metformin+glimepiride

Glimepiride DRUG

At same dosage as during the run-in period

insulin glargine+metformin+glimepiride; insulin glulisine+insulin glargine+metformin+glimepiride

Insulin Glulisine DRUG

One bolus given before the main meal

insulin glulisine+insulin glargine+metformin+glimepiride

Metformin DRUG

At same dosage as during the run-in period

insulin glargine+metformin+glimepiride; insulin glulisine+insulin glargine+metformin+glimepiride

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes Mellitus, Type 2
• \< BMI \< 45 kg/m²
• ,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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Sanofi-aventis

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis

Moscow, Russia

Location

Sanofi-aventis

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Glargine; glimepiride; insulin glulisine; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Medical Affairs study director
• Organization: sanofi-aventis

publicregistryGMA@sanofi-aventis.com

Study Officials

• PILORGET Valérie, MD

  Sanofi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 3, 2006
• First Posted: August 7, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: August 8, 2011
• Results First Posted: December 2, 2009

Record last verified: 2011-08

Locations

GB (1); RU (1); US (1)