Comparative investigation of Insuline glargine versus Metformin as first line drug in treat-ment of early Type 2 Diabetes (GLORY) - GLORY

• Conditions: Diabetes mellitus Type II; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2008-006860-12-DE
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-19
• Last Update Posted: 17 July 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

- Patients with Type II Diabetes mellitus (less than 5 years)
- Age between 35 and 75
- HbA1C > 6,5% < 8,0% (8,5% if previously treated with OAD (oral antidiabetikum))
- Signed informed consent form

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Treatment with more than one OAD
- Treatment with 1 OAD within the last 6 weeks
- Treatment with insuline
- History of cardiovascular disease < 6 months
- Significant hepatic disease (ALAT/ASAT> 2,5 times of normal range) or alcohol
intoxication
- Significant renal diseases (Kreatinin >1,2 mg/dl or Kreatinin-Clearance<60ml/min)
- Circumstances which can cause renal insufficiency, e.g. dehydration, severe
infections, shock
- Treatment with systemic, oral or injectable Corticosteroids
- Diseases of the adrenal gland, hypophysis, thyroid gland, which are not appropriate
for the study procedure (investigators estimation)
- Intravascular administration of contrast agents containing iodine
- Diabetic ketoacidosis
- Acute or chronic diseases that can cause tissue hypoxie like cardiac or respiratory
insufficiency, myocardic infarct, shock
- Known allergic or hypersensitiv reaction to one of the study drug or to drugs with
similar chemical structures
- Lack of compliance or other similar reason, that according to investigator, precludes
satisfactory participation of the study
- Participation in another clinical trial within the last 4 weeks
- History of drug or alcohol abuse or psychological sickness that does not allow the
subject to understand the nature and procedures of the study
- Pregnant and lactating women
- Women of childbearing potential not actively and consistently practicing birth control
by using a medically accepted device or therapy (error rate <1%)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - Protection of B cells (HbA1c, C-Peptide, Proinsulin)<br>- Glycemic variability (standard deviation, MAGE=mean amplitude of glucose excursions)<br>- Glycemic Load<br>- Free fatty acids<br>- Antiinflammatory effect of insuline (hsCRP, PAI-1, Leucocytes)<br>- Effect on endothelial function (Laser-Doppler O2C)<br>- Renal effects (Microalbuminurie)<br>- Hypoglycemic risk (time < 3mmol glucose)<br><br>;Primary end point(s): AUC within 2 h (postprandial) [mmol/L/time] before and after treatment (after 36 weeks) with Insuline glargin as well as with Metformin.;Main Objective: To compare the treatment of an early Type II Diabetes mellitus with Insuline instead of the conventional treatment with Metformin.<br>Evaluation of efficacy and safety of an early Diabetes mellitus Type II therapy with Insuline glargine as first line drug compared to treatment with Metformin described by the Area Under Curve (AUC) [mmol/L/time] measured with continous glucose monitoring.