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CompletedNCT00272012Updated Dec 7, 2009

OPAL - Insulin Glulisine, Diabetes Mellitus

A Phase 3 interventional study of Insulin glulisine in Diabetes Mellitus Type 2, sponsored by Sanofi. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-07.

Sponsored by Sanofi · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
396
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. The aim of the study is to demonstrate two-sided equivalence between the two therapy regimens receiving two different injection timing of Insulin glulisine.

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
02

Conditions studied

  • Diabetes Mellitus Type 2
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 396 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Sanofi is the lead sponsor of 1,508 studies on the registry; 90 are open to participants now.

Of its 198 completed or terminated interventional studies of FDA-regulated products, 118 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion criteria:

  • 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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
396 participants (actual)

Interventions

  • DrugInsulin glulisine
06

What researchers measure

Primary outcomes

  1. Change in HbA1c.

    Time frame: from baseline to study endpoint.

Secondary outcomes

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

    Time frame: 8-point profile

  2. Fasting blood glucose

    Time frame: 8-point blood glucose profile values

  3. Responder rate HbA1c smaller 7 %

    Time frame: at study endpoint

  4. Insulin dose

    Time frame: rapid-acting, basal and total daily doses

  5. Weight, BMI

    Time frame: study follow-up

  6. Hypoglycemic events

    Time frame: study follow-up

  7. Adverse events.

    Time frame: study follow-up

07

Study locations

1 site
  • Sanofi-Aventis
    Berlin, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00272012
Lead sponsor
Sanofi
First posted
Jan 4, 2006
Start date
Jul 2004
Primary completion
Sep 2006
Last update
Dec 7, 2009

Study contacts

Wolfgang Landgraf, Dr.
study director · Sanofi
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.

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