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OpenTrials
Completed

NCT Number: NCT00272012

OPAL - Insulin Glulisine, Diabetes Mellitus

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

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Key information

Conditions

Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Berlin, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

insulin glulisine

Drug

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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
First posted
Jan 4, 2006
Registry last updated
Dec 7, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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