Insulin Glulisine in Type 2 Diabetic Patients | RxWiki

Insulin Glulisine in Type 2 Diabetic Patients

Overview[ - collapse ][ - ]

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	Diabetes Mellitus, Type 2
Intervention	Drug: Insulin Glargine Drug: Glimepiride Drug: Insulin Glulisine Drug: Metformin
Phase	Phase 4
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00360698
First Received	August 3, 2006
Last Updated	August 1, 2011
Last verified	August 2011

Tracking Information[ + expand ][ + ]

First Received Date	August 3, 2006
Last Updated Date	August 1, 2011
Start Date	July 2006
Estimated Primary Completion Date	August 2008
Current 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%
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	Insulin Glulisine in Type 2 Diabetic Patients
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.
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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	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
Study Arm (s)	Other: insulin glulisine+insulin glargine+metformin+glimepiride Bolus arm Other: insulin glargine+metformin+glimepiride Control arm

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	106
Estimated Completion Date	August 2008
Estimated Primary Completion Date	August 2008
Eligibility 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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States, Bulgaria, Russian Federation, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT00360698
Other Study ID Numbers	HMR1964A_4002
Has Data Monitoring Committee	Not Provided
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: PILORGET Valérie, MD Sanofi
Verification Date	August 2011

Locations[ + expand ][ + ]