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Effect of Different Insulin Administrations, All in Combination With Metformin, on Glycaemic Control in Subjects With Type 2 Diabetes Inadequately Controlled by Oral Anti-diabetic Drugs

NCT01068652 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 403

Last updated 2017-01-13

Study results available
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Summary

This trial is conducted in Africa. The aim of this clinical trial is to investigate the effect of 50 weeks of treatment with different intensified insulin administrations (all in combination with a fixed dose of metformin) on blood sugar control in subjects with type 2 diabetes inadequately controlled by oral anti-diabetic drugs (OADs).

Conditions

Interventions

DRUG

insulin detemir

Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).

DRUG

insulin aspart

Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin)

DRUG

biphasic insulin aspart 30

Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily

DRUG

metformin

1000-2000 mg/day in combination with insulin treatment

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Algeria
  • Egypt
  • Morocco
  • South Africa
  • Tunisia

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068652 on ClinicalTrials.gov