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Type 1 Diabetes MellitusPhase 1NCT01195454

Euglycemic Clamp Dose-response Study Comparing a New Insulin Glargine Formulation With Lantus®

A Phase 1 study testing Insulin glargine (HOE901) in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.

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

Primary Objective: To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus® Secondary Objectives: To assess the exposure ratios of a new insulin glargine formulation versus Lantus® To compare the duration of action of a new insulin glargine formulation versus Lantus® To explore… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Insulin glargine (HOE901)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteGermany
Study dates
Aug 2010to Dec 2010
Phase
Phase 1
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female subjects with diabetes mellitus type 1 for more than one year,
  • Total insulin dose of <1.2 U/kg/day,
  • Glycohemoglobin (HbA1c) ≤ 9.0%,
  • Fasting negative serum C-peptide (< 0.3 nmol/L),
  • Stable insulin regimen for at least 2 months prior to study,
  • Normal findings in medical history and physical examination (cardiovascular system, chest and lungs, thyroid, abdomen, nervous system, skin and mucosae, and musculo-skeletal system), vital signs, electrocardiogram (ECG) and safety lab,
  • Women of childbearing potential with negative pregnancy test and use of a highly effective contraceptive method or women with confirmed postmenopausal status.

Who cannot join

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness,
  • More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months,
  • Frequent severe headaches and / or migraine, recurrent nausea and / or vomiting (more than twice a month),
  • Symptomatic hypotension (whatever the decrease in blood pressure), or asymptomatic postural hypotension defined by a decrease in SBP equal to or greater than 20 mmHg within three minutes when changing from the supine to the standing position,
  • Presence or history of a drug allergy or clinically significant allergic disease,
  • Likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol,
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  • Pregnant or breast feeding women,
  • Any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic half-life of that drug, whichever the longest and regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days,
  • Positive reaction to any of the following tests: hepatitis B surface (HBs Ag) antigen, antihepatitis B core antibodies (anti-HBc Ab) if compound having possible immune activities, anti-hepatitis C virus (anti-HCV2) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab),
  • Known hypersensitivity to insulin glargine and excipients,
  • Any history or presence of deep leg vein thrombosis.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Sanofi-Aventis Administrative Office

    Berlin

Other trials in Germany

About this study

Primary Objective:

  • To assess the total metabolic effect ratios of a new insulin glargine formulation versus Lantus®

Secondary Objectives:

  • To assess the exposure ratios of a new insulin glargine formulation versus Lantus®
  • To compare the duration of action of a new insulin glargine formulation versus Lantus®
  • To explore the dose response and dose exposure relationship of a new insulin glargine formulation
  • To assess the safety and tolerability of a new insulin glargine formulation
Read the detailed description

The study period for one patient is one month in average and it can last up to 11 weeks broken down as follows:

  • Screening: 3 to 28 days
  • Treatment period: 1 to 4 days: 2 days (1 overnight stay)
  • Washout period: 5 to 18 days (preferentially 7 days between consecutive dosings)
  • End of study: 1 day after the last dosing
Being tested
Insulin glargine (HOE901)
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 glargine (HOE901)Drug

    Pharmaceutical form: Lantus solution for injection

    Route of administration: subcutaneous

  • Insulin glargine (HOE901)Drug

    Pharmaceutical form: New insulin glargine formulation solution for injection

    Route of administration: subcutaneous

Study groups in NCT01195454
Study groupRoleWhat they receive
Insulin glargine / New insulin glargine formulationExperimental* Period 1: Insulin glargine * Period 2: New insulin glargine formulation * Period 3: New insulin glargine formulation * Period 4: New insulin glargine formulation Duration of treatment: 1 day at each period
Receives: Drug: Insulin glargine (HOE901)

What is being measured

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

  1. The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36)

    Measured: 36 hours (D1 to D2) in all four treatment periods

Secondary outcomes (6)

  1. The area under the insulin glargine concentration curve within 36 hours (INS-AUC0-36) -

    Measured: 36 hours (D1 to D2) in all four treatment periods

  2. Time to 50% of the GIR-AUC0-36 (T50%-GIR AUC0-36)

    Measured: 36 hours (D1 to D2) in all four treatment periods

  3. Time to 50% of INS-AUC0-36 (T50% INS-AUC0-36)

    Measured: 36 hours (D1 to D2) in all four treatment periods

  4. Duration of blood glucose control (time to elevation of smoothed blood glucose profile above clamp level and to elevation above different pre-specified blood glucose levels)

    Measured: 36 hours (D1 to D2) in all four treatment periods

  5. Maximum smoothed body weight standardized glucose infusion rate GIRmax, and time to GIRmax (GIR-Tmax)

    Measured: 36 hours (D1 to D2) in all four treatment periods

  6. Maximum insulin concentration INS-Cmax, and time to Cmax (INS-Tmax)

    Measured: 36 hours (D1 to D2) in all four treatment periods

Timeline

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

  1. First posted6 Sep 2010 (estimated)
  2. Study startAug 2010
  3. Primary completionNov 2010
  4. Study completionDec 2010

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01195454
Sponsor's protocol ID
PKD11627
Other IDs
2010-020914-27
Status last verified
Oct 2011
First submitted
3 Sep 2010
Last updated
31 Oct 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin glargine (HOE901) in people with Type 1 Diabetes Mellitus, run by Sanofi at 1 site in Germany.

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 7 inclusion and 12 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 31 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The area under the body weight standardized glucose infusion rate curve (GIR) within 36 hours (GIR-AUC0-36) (time frame: 36 hours (D1 to D2) in all four treatment periods). 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 NCT01195454.

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 31 Oct 2011.

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