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Completed

NCT Number: NCT00857870

Insulin Glargine First Line vs Metformin in Type 2 Diabetic Subjects

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.

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Key information

Conditions

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

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

GWT -TUD, Center for Clinical Studies

Dresden, 01307, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

metformin

Drug

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.

insulin glargine

Drug

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.

Primary outcomes

  1. Area under the curve (AUC) after a testmeal measured CGM.

    Time frame: baseline and visit 8

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Registry information

Official study title

Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes

Acronym: GLORY

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Mar 9, 2009
Registry last updated
Jan 11, 2012

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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