- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00857870
Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects (GLORY)
Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Dresden, Germany, 01307
- GWT -TUD, Center for Clinical Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- early type 2 diabetes (lower than 5 years known)
- male and female(35 to 75 years)
- HbA1c 7 to 8 %, if drug naive and <= 8.5 with previous OAD intake
- Informed consent
Exclusion Criteria:
- any treatment more than one OAD at the same time
- treatment with one OAD < 6 weeks time
- insulin treatment
- acute coronary syndrome < 6 months
- severe liver disease
- alcohol abuse or drug addiction
- severe kidney disease
- acute critical illness with renal impairment
- i.v. application of iodine
- ketoacidosis
- acute or chronic illness witch may lead to hypoxia or cardial failure
- allergy against one of the drugs
- deficit in compliance or cooperation
- pregnancy or breast feeding
- women in fertile age without accepted contraceptive
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Insulin glargine
|
Insulin glargine is given subcutaneously with an insulin-pen (SoloStar®).
The dose was titrated to reach a fasting plasma glucose value of <5.6 mmol/l.
Insulin glargine was given once a day in the evening before going to bed (bed-time injection).
The first insulin injection takes place on the evening of visit 1c.
The duration of the therapy is 36 weeks until visit 8c.
All patients were trained in handling and storage of the insulin-pen.
|
Active Comparator: Metformin
|
Metformin is administered as coated tablet. Initial dose is 500 mg twice a day (morning and evening) during or after the meal. The first administration takes place on the evening of visit 1c. The duration of the therapy is 36 weeks until visit 8c. Initial dose of 500 mg bid was increased after 4 weeks (visit 2) to 850 mg bid when the patient tolerated the initial dose. If the side effects were not tolerable, the initial dose was decreased to 500 mg once a day and where appropriate increased at a later visit. After 8 weeks (visit 3) metformin dose was increased to 1000 mg bid when tolerated. If dose is not tolerated, it was decreased to the next lower dose. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the curve (AUC) after a testmeal measured CGM.
Time Frame: baseline and visit 8
|
baseline and visit 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1C, glycemic variability, glycemic load, insulin secretion after testmeal, free fatty acids, biomarkers of low grade inflammation, endothelial dysfunction.
Time Frame: baseline and visit 8
|
baseline and visit 8
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GWT-2008-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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