Insulin Glulisine in Type 2 Diabetic Patients - Full Text View

Sponsor:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00360698

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Glimepiride Insulin glargine Insulin glulisine Metformin Metformin hydrochloride

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Glycolysated Haemoglobin (HbA1c) Value [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
Change in Glycolysated 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 ]
Daily Dose of Insulin Glulisine [ Time Frame: at the end of treatment (week 24) ] [ Designated as safety issue: No ]
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
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-Aventis

Investigators

Study Director:

PILORGET Valérie, MD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers:	HMR1964A_4002, EUDRACT # : 2005-002614-38
Study First Received:	August 3, 2006
Results First Received:	August 20, 2009
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00360698 History of Changes
Health Authority:	United States: Institutional Review Board; United States: Food and Drug Administration

Additional relevant MeSH terms:

Metabolic Diseases
Insulin glulisine
Immunologic Factors
Metformin
Physiological Effects of Drugs
Diabetes Mellitus
Endocrine System Diseases
Cardiovascular Agents
Immunosuppressive Agents

Insulin
Pharmacologic Actions
Glimepiride
Hypoglycemic Agents
Therapeutic Uses
Diabetes Mellitus, Type 2
Glargine
Anti-Arrhythmia Agents
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010