Insulin Glulisine in Type 2 Diabetic Patients

Diabetes Mellitus, Type 2 Clinical Trial

— Basal Plus  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360698
• Other study ID #: HMR1964A_4002
• Secondary ID: EUDRACT # : 2005
• Status: Completed
• Phase: Phase 4
• First received: August 3, 2006
• Last updated: August 1, 2011
• Start date: July 2006
• Est. completion date: August 2008

Study information

• Verified date: August 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Glargine
One daily injection at bedtime
• Glimepiride
At same dosage as during the run-in period
• Insulin Glulisine
One bolus given before the main meal
• Metformin
At same dosage as during the run-in period

Locations

Country	Name	City	State
Russian Federation	Sanofi-Aventis	Moscow
United Kingdom	Sanofi-aventis	Guildford
United States	Sanofi-aventis	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Russian Federation,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Glycosylated Haemoglobin (HbA1c) Value		at the end of treatment (week 24)	No
Secondary	Change in Glycosylated Haemoglobin (HbA1c) Value		from baseline to the end of treatment (week 24)	No
Secondary	Daily Mean Plasma Glucose		at the end of treatment (week 24)	No
Secondary	Change in Daily Mean Plasma Glucose		from baseline to the end of treatment (week 24)	No
Secondary	Change in Weight		from baseline to the end of treatment (week 24)	No
Secondary	Daily Dose of Insulin Glargine	Mean of 3 daily doses reported during the week prior to the final visit	at the end of treatment (week 24)	No
Secondary	Daily Dose of Insulin Glulisine	Mean of 3 daily doses reported during the week prior to the final visit	at the end of treatment (week 24)	No
Secondary	Rate of Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL		during treatment period (12 weeks)	No
Secondary	Rate of Nocturnal Symptomatic Hypoglycemia With Plasma Glucose < 70mg/dL		during treatment period (12 weeks)	No
Secondary	Rate of Severe Symptomatic Hypoglycemia		during treatment period (12 weeks)	No