NCT00046150

Brief Summary

The purpose of this study is to compare the safety of HMR 1964 and insulin aspart when used in external pumps with respect to catheter occlusions, GHb assessment, insulin doses, blood glucose parameters, hypoglycemic episodes, unexplained hyperglycemia, adverse events, laboratory data, and vital signs.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2002

Shorter than P25 for phase_3

Geographic Reach
3 countries

3 active sites

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

May 1, 2002

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2002

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 23, 2002

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
Last Updated

June 19, 2008

Status Verified

June 1, 2008

First QC Date

September 20, 2002

Last Update Submit

June 18, 2008

Conditions

Diabetes, Type I

Outcome Measures

Primary Outcomes (1)

  • Frequency of catheter occlusions

Secondary Outcomes (1)

  • Unexplained hyperglycemia, parameters of glycemic control

Interventions

Insulin glulisine (HMR1964)DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects meeting all of the following criteria will be considered for enrollment into the study:
  • Men and women above the age of 18.
  • Women are either not of childbearing potential (surgically sterile, or postmenopausal for more than 2 years) or are not pregnant and agree to use a reliable contraceptive measure for the duration of the study. Reliable contraceptive measures include the follows: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
  • Type 1 diabetes mellitus as established in the medical history (for the purpose of this protocol: onset of diabetes under the age of 40 and has required continuous insulin therapy since diagnosis).
  • At least 1 year of continuous insulin treatment with at least 6 months of continuous subcutaneous insulin infusion treatment immediately prior to study entry.
  • Use of the same type of external insulin pump (MiniMed programmable pump, or Disetronic pump type H Tron Plus V 100 or D Tron) for at least 3 months prior to study entry.
  • HbA1c \<8.5% measured at visit 1.
  • Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home.
  • Informed consent must be obtained in writing for all subjects at enrollment into the study (see Section 12.3).

You may not qualify if:

  • Subjects presenting with any of the following will not be included in the study:
  • Active proliferative diabetic retinopathy, as defined by the application of focal or panretinal photocoagulation or vitrectomy, in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require surgical treatment (including laser photocoagulation) during the study.
  • Diabetes other than type 1 diabetes mellitus.
  • History of serious ketosis episode requiring hospitalization in the 3 previous months.
  • History of abscess at the infusion site in the previous 3 months.
  • Pancreatectomised subjects.
  • Subjects who have undergone pancreas and or islet cell transplants.
  • Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol (see Section 6.2).
  • Treatment with any investigational drug in the last month before visit 1.
  • History of seizure disorders.
  • History of hypersensitivity to insulin or insulin analogues or any other excipients in the HMR1964 or insulin aspart formulation (see the Global Investigators Brochure \[7\] and the insulin aspart SPC \[13\] for a list of excipients).
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, active cancer, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult or would, in the opinion of the investigator, preclude the safe participation of the subject in this protocol.
  • History of drug or alcohol abuse.
  • Impaired hepatic function, as shown by but not limited to ALT or AST greater than twice the normal upper limit measured at visit 1.
  • Impaired renal function, as shown by but not limited to serum creatinine \>177 micromol/L (\>2.0 mg/dL) measured at visit 1.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital de Rangueil

Toulouse, 31403, France

Location

Sanofi-aventis Administrative Office

Berlin, Germany

Location

Sanofi-aventis Administrative Office

Gouda, Netherlands

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • ICD CSD

    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

September 20, 2002

First Posted

September 23, 2002

Study Start

May 1, 2002

Study Completion

December 1, 2002

Last Updated

June 19, 2008

Record last verified: 2008-06

Locations

FR(1)DE(1)NL(1)