Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects (GLORY)

GWT-TUD

Status and phase: Completed; Phase 4

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin glargine; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT00857870

GWT-2008-1

Details and patient eligibility

About

Comparison of efficacy and safety of glargine insulin and metformin as first line drug of patients insufficiently treated with lifestyle intervention. So far treatment also algorithm with lifestyle and metformin has not been evaluated in patients with type 2 diabetes and HbA1C greater or equal 7 % and lower than 8.1%.Besides HbA1C postprandial glucose excursion and glycemic variability as determinants of oxidative stress will be measured by continuous glucose measurement(CGM). Further more CGM will reveal risk of hypoglycemia at night. As secondary objectives effect on endothelial function, renal function and biomarkers of low great inflammation will be evaluated. So far only scarce information on face to face comparison in ealy diabetes exists.

Enrollment: 96 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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96 participants in 2 patient groups

Metformin

Active Comparator group

Treatment:

Drug: Metformin

Insulin glargine

Active Comparator group

Treatment:

Drug: Insulin glargine