12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00046150
• Date of registration: 20/09/2002
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: 12 Week,Comparing Safety of HMR1964 & Insulin Aspart Used in Continuous Subcutaneous Infusion in Type 1 Diabetes.
• Scientific title: 12-Week, Multinational, Multicenter, Controlled, Open, 1:1 Randomized, Parallel Clinical Trial Comparing the Safety of HMR1964 and Insulin Aspart Used in Continuous Subcutaneous Insulin Infusion (CSII) in Subjects With Type 1 Diabetes Mellitus
• Date of first enrolment: May 2002
• Target sample size: 59
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00046150
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

France, Germany, Netherlands

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

INCLUSION CRITERIA:

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).

EXCLUSION CRITERIA:

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.

- Pregnancy (as determined by pregnancy blood test at visit 1) or breast-feeding.

- Night shift workers.

- Mental condition rendering the subject unable to understand the nature, scope, and
possible consequences of the study.

- Subject unlikely to comply with protocol, e.g. an inability and unwillingness to
participate in adequate training, an uncooperative attitude, inability to return for
follow-up visits, and unlikelihood of completing the study.

- Employee of the sponsor or of sponsor representatives.

- Subjects who have previously been treated with HMR1964.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes, Type I

Intervention(s)

Drug: Insulin glulisine (HMR1964)

Primary Outcome(s)

Frequency of catheter occlusions

Secondary Outcome(s)

Unexplained hyperglycemia, parameters of glycemic control

Secondary ID(s)

HMR1964/3006

HMR1964

Source(s) of Monetary Support

Please refer to primary and secondary sponsors