Efficacy and Safety of Insulin Glulisine in Type 2 Diabetes Mellitus

NCT ID: NCT00290927

Last Updated: 2009-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 390 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-12-31

Brief Summary

• 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

insulin glulisine

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Principal Investigators

Masayoshi KOYAMA

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis

Tokyo, , Japan

Countries

Japan

References

Kawamori R, Iwamoto Y, Kadowaki T, Iwasaki M, Kim SW, Woo JT, Baik SH, Yoon KH. Effects of insulin glulisine as mono- or add-on therapy in patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2009 Sep;11(9):900-9. doi: 10.1111/j.1463-1326.2009.01088.x. Epub 2009 Jul 13.

Reference Type: RESULT

PMID: 19614946 (View on PubMed)

Other Identifiers

EFC6168

Identifier Type: -

Identifier Source: org_study_id