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Diabetes Mellitus Type 2Phase 3NCT00272012

OPAL - Insulin Glulisine, Diabetes Mellitus

A Phase 3 study testing Insulin glulisine in people with Diabetes Mellitus Type 2, 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: The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Insulin glulisine
How many people
396 participants
Where
1 siteGermany
Study dates
Jul 2004to Sep 2006
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

  • Type 2 Diabetes mellitus, previously treated with combination therapy of insulin glargine + OAD (maximal tolerated dose / approved in combination with insulin according to local SPCs (Summary of Product Characteristics), not including use of a-glucosidase inhibitors) for at least 3 months
  • Pre-screening HbA1c value greater/equal 7% - smaller/equal 9%
  • FBG (Fasting Blood Glucose) smaller/equal 120 mg/dl (6.6 mmol/l)
  • 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 following: systemic contraceptive (oral, implant, injections), diaphragm with intravaginal spermicide, cervical cap, intrauterine device, or condom with spermicide.
  • Ability and willingness to perform blood glucose monitoring using the sponsor-provided blood glucose meter and subject diary at home

Who cannot join

  • More than two FBG greater 120 mg/dl (6.6 mmol/l) as measured on 5 consecutive days before visit II
  • 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)
  • Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
  • Known impaired hepatic and renal function
  • History of drug or alcohol abuse
  • History of hypersensitivity to insulin or insulin analogues or any of the excipients in the Insulin glulisine formulation
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  • Treatment with any investigational drug in the last month before visit I
  • Pregnant or breast-feeding women, or women planning to become pregnant during the study
  • Treatment or likelihood of requiring treatment during the study period with drugs not permitted by the clinical study protocol
  • Night shift workers if they are unable to comply with the treatment regimen

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Sanofi-Aventis

    Berlin

Other trials in Germany

About this study

Official title: Efficacy and Safety of Insulin Glulisine Given as a Single Injection at Breakfast + Insulin Glargine+OAD (Oral Antidiabetic Drug) vs Insulin Glulisine Given as a Single Injection at Main Meal+Insulin Glargine+OAD in Type 2 Diabetic Patients for Which Glycemic Control is Suboptimal Using Insulin Glargine+ OAD Alone

Primary objective:

The primary study objective is to compare efficacy of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of change in HbA1c, from baseline to endpoint for the individual patient. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.

Read more

Secondary objective:

Secondary study objectives are to compare efficacy and safety of Insulin glulisine, once a day at breakfast vs. Insulin glulisine given once a day at main meal in combination with insulin glargine + OAD in terms of:

  • Change of fasting-, pre-/2h-postprandial-, mean daily and nocturnal blood glucose (baseline to endpoint)
  • Change of fasting plasma glucose (baseline to endpoint)
  • Response rate: Responders will be those patients with HbA1c smaller than 7.0% at study endpoint
  • Insulin dose (rapid-acting, basal and total daily doses)
  • Weight, body-mass index
  • Hypoglycemic events
  • Adverse events
Being tested
Insulin glulisine
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Insulin glulisineDrug

What is being measured

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

  1. Change in HbA1c.

    Measured: from baseline to study endpoint.

Secondary outcomes (7)

  1. Change of pre-, 2 h postprandial and nocturnal blood glucose values

    Measured: 8-point profile

  2. Fasting blood glucose

    Measured: 8-point blood glucose profile values

  3. Responder rate HbA1c smaller 7 %

    Measured: at study endpoint

  4. Insulin dose

    Measured: rapid-acting, basal and total daily doses

  5. Weight, BMI

    Measured: study follow-up

  6. Hypoglycemic events

    Measured: study follow-up

  7. Adverse events.

    Measured: study follow-up

Timeline

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

  1. First posted4 Jan 2006 (estimated)
  2. Study startJul 2004
  3. Primary completionSep 2006

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
396 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00272012
Sponsor's protocol ID
HMR1964A_3507
Status last verified
Dec 2009
First submitted
2 Jan 2006
Last updated
7 Dec 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Insulin glulisine in people with Diabetes Mellitus Type 2, 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 5 inclusion and 10 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 7 Dec 2009. 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 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?

Change in HbA1c. (time frame: from baseline to study endpoint.). 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 NCT00272012.

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 7 Dec 2009.

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