NCT00290927

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P50-P75 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 13, 2006

Completed
Last Updated

August 26, 2009

Status Verified

March 1, 2009

First QC Date

February 10, 2006

Last Update Submit

August 25, 2009

Conditions

Diabetes Mellitus, Type 2

Keywords

HMR1964, insulin glulisine, Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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).

Interventions

insulin glulisineDRUG

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanofi-Aventis

Tokyo, Japan

Location

Related Publications (1)

  • 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.

    PMID: 19614946RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Masayoshi KOYAMA

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 10, 2006

First Posted

February 13, 2006

Study Start

December 1, 2003

Last Updated

August 26, 2009

Record last verified: 2009-03

Locations

JP(1)