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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT00857870
First received: March 6, 2009
Last updated: January 10, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
 Drug: Metformin
Drug: Insulin glargine
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Investigation of Efficacy and Safety of Insulin Glargine Versus Metformin as First Line Drug in Treatment of Early Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • Area under the curve (AUC) after a testmeal measured CGM. [ Time Frame: baseline and visit 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 96
Study Start Date: March 2009
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Metformin 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.
Active Comparator: Insulin glargine 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.

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857870

Locations
Germany
GWT -TUD, Center for Clinical Studies
Dresden, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
  More Information

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT00857870     History of Changes
Other Study ID Numbers: GWT-2008-1
Study First Received: March 6, 2009
Last Updated: January 10, 2012
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine
 Insulin
Metformin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013