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Diabetes, Type IPhase 3NCT00046150

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

A Phase 3 study testing Insulin glulisine (HMR1964) in people with Diabetes, Type I, run by Sanofi at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Type I
What is being tested?
Insulin glulisine (HMR1964)
How many people
59 participants
Where
3 sitesin 3 countries
Study dates
May 2002to Dec 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

France1 site

  • Hospital de Rangueil

    Toulouse, 31403

Other trials in France

Germany1 site

  • Sanofi-aventis Administrative Office

    Berlin

Other trials in Germany

Netherlands1 site

  • Sanofi-aventis Administrative Office

    Gouda

Other trials in Netherlands

About this study

Official 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

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.

Being tested
Insulin glulisine (HMR1964)
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin glulisine (HMR1964)Drug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Frequency of catheter occlusions

Secondary outcomes (1)

  1. Unexplained hyperglycemia, parameters of glycemic control

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2002 (estimated)
  2. Study startMay 2002
  3. Study completionDec 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00046150
Sponsor's protocol ID
HMR1964/3006
Other IDs
HMR1964
Status last verified
Jun 2008
First submitted
20 Sep 2002
Last updated
19 Jun 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glulisine (HMR1964) in people with Diabetes, Type I, run by Sanofi at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of catheter occlusions. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00046150.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2008.

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