Chronic Reduction of Fasting Glycaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:

Chronic Reduction of Fasting Gylcaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249677
• Other study ID #: 08- BO-LSBE
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2010
• Last updated: November 29, 2010
• Start date: January 2009
• Est. completion date: May 2010

Study information

• Verified date: October 2008
• Source: Ruhr University of Bochum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics commiteeGermany: Federal Institut for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes. The investigators examined, whether chronic basal insulin treatment with insulin glargine lead to improvements in glucose-induced insulin secretion.

Description:

14 patients with type 2 diabetes on previous metformin therapy were examined before and after eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia. Intravenous glucose tolerance tests were performed with and without previous adjustment of fasting glucose levels by means of a 3-hour intravenous insulin infusion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18 and 75 years, inclusive

2. BMI-range 27-50 kg/m²

3. patients with type 2 diabetes presenting with fasting hyperglycaemia (>126mg/dl) on metformin treatment

Exclusion Criteria:

1.Pre-existing insulin therapy, treatment with sulphonylureas, glitazones, 2.glinides, DPP-4-inhibitors or exenatide 3.patients with type 1 diabetes 4.Patients are investigator site personnel directly affiliated with the study, or are immediate family of investigator site personnel directly affiliated with the study. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.

5. Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner). A male subject who is sexually active and has not been surgically sterilised must be informed that he must either use a condom during intercourse, ensure that his partner practices contraception, or he must refrain from sexual intercourse during the trial and until 1 month after completion of the trial. This is to prevent the possibility of a pregnancy from spermatocytes that can potentially be damaged by trial medication. It is strongly recommended that the female partners use a highly effective contraception (Pearl Index < 1%).

6. Patients have participated in an interventional medical, surgical, or pharmaceutical study (a study in which an experimental, drug, medical, or surgical treatment was given) within 30 days prior to screening. This criterion includes drugs that have not received regulatory approval for any indication at the time of study entry.

7. Patients have alcohol consumption (>20 g daily for males and >10 g daily for females)

8. Patients have alanine aminotransaminase (ALT) greater than ten times the upper limit of the reference range.

9.Patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.

10. Patients have cardiac disease that is Class III or IV, according to the New York Heart Association criteria.

11. Patients have a history of renal transplantation or are currently receiving renal dialysis or have serum creatinine >1.8 mg/dL for males and greater than or equal to >1.5 mg/dL for females. 12.Patients have known hemoglobinopathy or chronic anemia 13.Patients are receiving chronic (lasting longer than 2 weeks) systemic glucocorticoid therapy (excluding topical and inhaled preparations) or have received such therapy within 2 weeks immediately prior to screening.

14. Patients have any other condition (including known drug or alcohol abuse or psychiatric disorder) that precludes them from following and completing the protocol, in the opinion of the investigator.

15. Patients fail to satisfy the investigator of suitability to participate for any other reason.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• insulin glargine
14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia.

Locations

Country	Name	City	State
Germany	Department of Medicine I; University Hospital St. Josef Hospital	Bochum

Sponsors (1)

Lead Sponsor	Collaborator
Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvements in first and second phase insulin secretion	Improvements in first and second phase insulin secretion after bedtime administration of insulin glargin, titrated to reach normal (90-100 mg/dl) fasting glucose levels	8 weeks	No