NCT00272012

CompletedPhase 3

OPAL - Insulin Glulisine, Diabetes Mellitus

Sanofi Source

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Other study identifiers

Sponsor study identifier

HMR1964A_3507

Study Type

interventional

Actual enrollment (reported)

396

Locations

1 country

Sites

1

Timeline

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

September 2006

Actual (reported)

Study Completion

Not reported

Date not reported

Brief 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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 396 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
July 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
January 2, 2006
Actual (reported)
First Posted
January 4, 2006
Actual (reported)
Primary Completion
September 2006
Actual (reported)

Last Updated: December 7, 2009
Status Verified: December 2009
Last Update Submitted: December 4, 2009

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c.
from baseline to study endpoint.

Secondary Outcomes (7)

Change of pre-, 2 h postprandial and nocturnal blood glucose values
8-point profile
Fasting blood glucose
8-point blood glucose profile values
Responder rate HbA1c smaller 7 %
at study endpoint
Insulin dose
rapid-acting, basal and total daily doses
Weight, BMI
study follow-up
+2 more secondary outcomes

Interventions

Insulin glulisineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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%

Sponsors & Collaborators

Sanofi
Industrylead

Study Sites (1)

Sanofi-Aventis

Berlin, Germany

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin glulisine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Wolfgang Landgraf, Dr.
Sanofi
STUDY DIRECTOR

Enrollment

396 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

January 2, 2006

First Posted

January 4, 2006

Study Start

July 2004

Date type not reported

This date has not been verified as actual or estimated.

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Phase 3Completed

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Phase 3Completed

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Phase 3Completed

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Phase 3Completed

NCT03529123

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Phase 3Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Primary Completion

September 2006

Actual (reported)

Last Updated

December 7, 2009

Record last verified: 2009-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00272012
Data provider: ClinicalTrials.gov
Source updated: 2009-12-07
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:18:59 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (7)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations