NCT00857870

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes

Timeline
Completed

Started Mar 2009

Typical duration for phase_4 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 9, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

2.4 years

First QC Date

March 6, 2009

Last Update Submit

January 10, 2012

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    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.

    baseline and visit 8

Study Arms (2)

Metformin

ACTIVE COMPARATOR
Drug: Metformin

Insulin glargine

ACTIVE COMPARATOR
Drug: Insulin glargine

Interventions

MetforminDRUG

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.

Metformin
Insulin glargineDRUG

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.

Insulin glargine

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GWT -TUD, Center for Clinical Studies

Dresden, 01307, Germany

Location

Related Publications (1)

  • Pistrosch F, Kohler C, Schaper F, Landgraf W, Forst T, Hanefeld M. Effects of insulin glargine versus metformin on glycemic variability, microvascular and beta-cell function in early type 2 diabetes. Acta Diabetol. 2013 Aug;50(4):587-95. doi: 10.1007/s00592-012-0451-9. Epub 2013 Feb 21.

    PMID: 23430192DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

MetforminInsulin Glargine

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsInsulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 9, 2009

Study Start

March 1, 2009

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

DE(1)