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
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: 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
Insulin, Globin Zinc
Glimepiride
Glargine
Insulin glulisine
Insulin
Hypoglycemic Agents
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 September 14, 2014