Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus - Full Text View

Purpose

To evaluate the superiority in the efficacy of HMR1964 and OHA combination therapy as compared with OHA therapy.
To evaluate the superiority in the efficacy of HMR1964 mono-therapy as compared with OHA therapy.
To evaluate the safety of HMR1964.

Condition	Intervention	Phase
Diabetes Mellitus, Type 2	Drug: insulin glulisine	Phase III

MedlinePlus related topics:

Diabetes

Drug Information available for:

Insulin Insulin glulisine

U.S. FDA Resources

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

Official Title:	Evaluation of Efficacy and Safety of HMR1964 Intensive Therapy in Subjects With Type 2 Diabetes Mellitus Not Optimally Controlled With Oral Hypoglycemic Agents (OHA); OHA Therapy Controlled, Open, Randomized, Parallel Group, Comparative (Superiority), 16-Week, Multinational, Multicenter Study

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Efficacy: change in HbA1C from baseline to endpoint (superiority of HMR1964 and OHA combination therapy as compared to OHA therapy, superiority of HMR1964 mono-therapy as compared to OHA therapy)
Safety of HMR1964

Secondary Outcome Measures:

change in HbA1C from baseline to week 16,consecutive change in HbA1C every 4 wks,plasma glucose parameters, symptomatic hypoglycemia (comparison of HMR1964 intensive therapy, mono-or OHA combination therapy, with OHA therapy).

Estimated Enrollment:	390
Study Start Date:	December 2003

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Men or women with type 2 diabetes mellitus diagnosed at least one year prior to the study with a BMI < 30 kg/m2 , a HbA1C of > 8.0 – < 11.0% at screening
Fasting serum C-peptide at screening > 0.7 ng/mL
Subjects who have been on a stable regimen and at the following doses of SU for at least 8 weeks prior to signing informed consent
Glibenclamide > 5 mg/day
Glimepiride > 3 mg/day
Gliclazide > 80 mg/day In addition to receiving the above mentioned SU agents, subjects may have been treated with a biguanide at a stable dose for at least 8 weeks prior to signing informed consent.
Subjects willing to administer three HMR1964 injections per day immediately prior to meals for a 16 week

Exclusion Criteria:

Subjects unwilling or incapable of receiving a starting dose of ≥ 0.2 IU/kg/day of HMR1964
Subjects with the likelihood of requiring concomitant treatment during the study period with the following classes of drugs: additional OHA (including thiazolidinediones, α-glucosidase inhibitors, D-phenylalanine derivative) other than those specified in the study protocol, insulin preparations other than HMR1964, systemic corticosteroids, other investigational products
Subjects with clinically relevant cardiovascular, hepatic, neurologic, endocrine diseases; and active cancer; or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
Subjects who are pregnant, breast feeding or wish to become pregnant during the study period
Subjects with diabetic retinopathy who received surgical treatments (laser photocoagulation or vitrectomy) within 12 weeks prior to informed consent, who are expected to have these surgical treatments during the study period, or who were diagnosed newly proliferative diabetic retinopathy within 12 weeks prior to informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00290927

Locations


Japan
	Sanofi-Aventis
	Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	Masayoshi KOYAMA	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Study ID Numbers:	EFC6168, HMR1964A
First Received:	February 10, 2006
Last Updated:	July 25, 2006
ClinicalTrials.gov Identifier:	NCT00290927
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Japan: Pharmaceuticals and Medical Devices Agency; South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Sanofi-Aventis:

HMR1964, insulin glulisine, Diabetes Mellitus, Type 2

Study placed in the following topic categories:

Insulin glulisine

Metabolic Diseases

Diabetes Mellitus, Type 2

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents

Physiological Effects of Drugs

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00290927