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Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

NCT00857870 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2012-01-11

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

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.

DRUG

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.

Sponsors & Collaborators

  • GWT-TUD GmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2011-08-31
Completion
2011-12-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00857870 on ClinicalTrials.gov