Insulin Glulisine in Type 2 Diabetic Patients (Basal Plus)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00360698
First received: August 3, 2006
Last updated: August 1, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Insulin Glargine
Drug: Glimepiride
Drug: Insulin Glulisine
Drug: Metformin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Patients With Glycosylated Haemoglobin (HbA1c) Value < 7% [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
    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%


Secondary Outcome Measures:
  • Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
  • Change in Glycosylated Haemoglobin (HbA1c) Value [ Time Frame: from baseline to the end of treatment (week 24) ] [ Designated as safety issue: No ]
  • Daily Mean Plasma Glucose [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
  • Change in Daily Mean Plasma Glucose [ Time Frame: from baseline to the end of treatment (week 24) ] [ Designated as safety issue: No ]
  • Change in Weight [ Time Frame: from baseline to the end of treatment (week 24) ] [ Designated as safety issue: No ]
  • Daily Dose of Insulin Glargine [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
    Mean of 3 daily doses reported during the week prior to the final visit

  • Daily Dose of Insulin Glulisine [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
    Mean of 3 daily doses reported during the week prior to the final visit

  • Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL [ Time Frame: during treatment period (12 weeks) ] [ Designated as safety issue: No ]
  • Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL [ Time Frame: during treatment period (12 weeks) ] [ Designated as safety issue: No ]
  • Rate of Severe Symptomatic Hypoglycemia [ Time Frame: during treatment period (12 weeks) ] [ Designated as safety issue: No ]

Enrollment: 106
Study Start Date: July 2006
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
insulin glulisine+insulin glargine+metformin+glimepiride
Bolus arm
Drug: Insulin Glargine
One daily injection at bedtime
Drug: Glimepiride
At same dosage as during the run-in period
Drug: Insulin Glulisine
One bolus given before the main meal
Drug: Metformin
At same dosage as during the run-in period
insulin glargine+metformin+glimepiride
Control arm
Drug: Insulin Glargine
One daily injection at bedtime
Drug: Glimepiride
At same dosage as during the run-in period
Drug: Metformin
At same dosage as during the run-in period

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  • History of drug or alcohol abuse

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: NCT00360698

Locations
United States, New Jersey
Sanofi-aventis
Bridgewater, New Jersey, United States, 08807
Russian Federation
Sanofi-Aventis
Moscow, Russian Federation
United Kingdom
Sanofi-aventis
Guildford, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
Study Director: PILORGET Valérie, MD Sanofi
  More Information

No publications provided

Responsible Party: Trial Transparency Team, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00360698     History of Changes
Other Study ID Numbers: HMR1964A_4002, EUDRACT # : 2005-002614-38
Study First Received: August 3, 2006
Results First Received: August 20, 2009
Last Updated: August 1, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glimepiride
Glargine
Insulin glulisine
Insulin
Hypoglycemic Agents
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 April 20, 2014