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

November 23, 2016 updated by: Novo Nordisk A/S

Effect of 50-week Treatment With Stepwise Insulin Intensification of Basal-bolus Insulin Analogues (Insulin Detemir and Aspart) or Biphasic Insulin Aspart 30 (NovoMix 30) All in Combination With Fixed Dose of Metformin on Glycaemic Control (Measured as HbA1c) in Subjects With Type 2 Diabetes. Open Labelled, Randomized, Two-arm, Parallel Group, Multi-centre, Multi-national Trial

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Ain Témouchent, Algeria, 46000
        • Novo Nordisk Investigational Site
      • Alger, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
      • Oran, Algeria, 31000
        • Novo Nordisk Investigational Site
      • Setif, Algeria, 19000
        • Novo Nordisk Investigational Site
      • Sidi Bel Abbes, Algeria, 22000
        • Novo Nordisk Investigational Site
  • Egypt
      • Alexandria, Egypt, 21131
        • Novo Nordisk Investigational Site
  • Morocco
      • Casablanca, Morocco, 20000
        • Novo Nordisk Investigational Site
  • South Africa
      • Sandton, South Africa, 2146
        • Novo Nordisk Investigational Site
    • Eastern Cape
      • Port Elizabeth, Eastern Cape, South Africa, 6014
        • Novo Nordisk Investigational Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 1812
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0083
        • Novo Nordisk Investigational Site
      • Pretoria, Gauteng, South Africa, 0002
        • Novo Nordisk Investigational Site
      • Vaderbijlpark, Gauteng, South Africa, 1900
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4450
        • Novo Nordisk Investigational Site
      • Durban, KwaZulu-Natal, South Africa, 4170
        • Novo Nordisk Investigational Site
    • Northern Cape
      • Kimberly, Northern Cape, South Africa, 8301
        • Novo Nordisk Investigational Site
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7945
        • Novo Nordisk Investigational Site
  • Tunisia
      • Tunisia, Tunisia, 1053
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
  • Diagnosed type 2 diabetes (WHO 1999 criteria)
  • Currently treated with suboptimal daily dose of OADs (mono or combination therapy) for at least 6 months
  • Male or female age at least 18 years old
  • HbA1c at least 7.0 % and maximum 11.0% for subjects treated with metformin mono-therapy, or maximum 10% for subjects treated with OAD combination therapy
  • BMI maximum 40 kg/m^2
  • Able and willing to perform self-monitoring of plasma glucose according to the protocol and to keep a diary
  • Able and willing to be treated with up to 4 insulin injections per day

Exclusion Criteria:

  • Known or suspected allergy to trial product(s) or related products
  • Previous participation in this trial. Participation is defined as randomisation
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice)
  • Participated in another clinical trial and received an investigational drug within the last weeks prior to the present trial
  • Impaired hepatic function defined as alanine aminotransferase (ALT) or alkaline phosphatase (ALP) at least 2.5 times upper referenced limit
  • Impaired renal function defined as serum-creatinine at least 1.3 mg/dL (at least 115 mmol/L) for males and at least 1.2 mg/dL (at least 106 mmol/L) for females
  • Subject has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association class III and IV)
  • Severe uncontrolled treated or untreated hypertension (sitting systolic blood pressure at least 180 mmHg or sitting diastolic blood pressure at least 100 mmHg)
  • Proliferative retinopathy or macular oedema requiring acute treatment
  • Metformin contraindications according to the package insert
  • Current treatment with systemic corticosteroids
  • Subject has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose additional risk in administering study drug to the subject
  • Current addiction to alcohol or other addictive substances as determined by the Investigator
  • Mental incapacity, unwillingness or language barrier precluding adequate understanding or cooperation in the study or use of the glucose monitor
  • History of hypoglycaemic unawareness and/or two or more severe hypoglycaemic episodes in the past year as judged by the Investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Detemir + Met
Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
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: metformin
1000-2000 mg/day in combination with insulin treatment
Active Comparator: BIAsp 30 + Met
Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
Drug: metformin
1000-2000 mg/day in combination with insulin treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycosylated Haemoglobin (HbA1c)
Time Frame: Week 50
Estimated mean difference in HbA1c after 50 weeks of treatment
Week 50

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Glycosylated Haemoglobin (HbA1c) After 14 Weeks of Treatment
Time Frame: Week 0, Week 14
Observed mean change from baseline in HbA1c at Week 14 (visit 11)
Week 0, Week 14
Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
Time Frame: Week 0, Week 26
Observed mean change in from baseline in HbA1c at Week 26 (visit 18)
Week 0, Week 26
Change in Glycosylated Haemoglobin (HbA1c) After 38 Weeks of Treatment
Time Frame: Week 0, Week 38
Observed mean change from baseline in HbA1c at Week 38 (visit 25)
Week 0, Week 38
Change in Glycosylated Haemoglobin (HbA1c) at Week 50
Time Frame: Week 0, Week 50
Observed mean change from baseline in HbA1c at Week 50 (visit 32)
Week 0, Week 50
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 14 Weeks of Treatment
Time Frame: Week 14
Number of subjects achieving HbA1c below 7.0% after 14 weeks of treatment (visit 11)
Week 14
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 26 Weeks of Treatment
Time Frame: Week 26
Number of subjects achieving HbA1c below 7.0% after 26 weeks of treatment (visit 18)
Week 26
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 38 Weeks of Treatment
Time Frame: Week 38
Number of subjects achieving HbA1c below 7.0% after 38 weeks of treatment (visit 25)
Week 38
Number of Subjects Achieving Glycosylated Haemoglobin (HbA1c) Below 7.0% After 50 Weeks of Treatment
Time Frame: Week 50
Number of subjects achieving HbA1c below 7.0% after 50 weeks of treatment (visit 32)
Week 50
Mean of Prandial Plasma Glucose (PG) Increment After 14 Weeks of Treatment
Time Frame: Week 14
Observed overall mean of PG increment after 14 weeks of treatment (Visit 11). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Week 14
Mean of Prandial Plasma Glucose (PG) Increment After 26 Weeks of Treatment
Time Frame: Week 26
Observed overall mean of PG increment after 26 weeks of treatment (visit 18). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}
Week 26
Mean of Prandial Plasma Glucose (PG) Increment After 38 Weeks of Treatment
Time Frame: Week 38
Observed overall mean of PG increment after 38 weeks of treatment (visit 25). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Week 38
Mean of Prandial Plasma Glucose (PG) Increment After 50 Weeks of Treatment
Time Frame: Week 50
Observed overall mean of PG increment after 50 weeks of treatment (visit 32). Mean PG Increment was calculated using the average of difference between the Post Prandial and Pre Prandial Glucose values {ie .average of (Post Breakfast - Pre Breakfast), (Post Lunch - Pre Lunch) and (Post Dinner - Pre Dinner)}.
Week 50
Mean of 8-point Plasma Glucose (PG) Profile After 14 Weeks of Treatment
Time Frame: Week 14
Observed overall mean of 8-point PG profile after 14 weeks of treatment (visit 11)
Week 14
Mean of 8-point Plasma Glucose (PG) Profile After 26 Weeks of Treatment
Time Frame: Week 26
Observed overall mean of 8-point PG profile after 26 weeks of treatment (visit 18)
Week 26
Mean of 8-point Plasma Glucose (PG) Profile After 38 Weeks of Treatment
Time Frame: Week 38
Observed overall mean of 8-point PG profile after 38 weeks of treatment (visit 25)
Week 38
Mean of 8-point Plasma Glucose (PG) Profile After 50 Weeks of Treatment
Time Frame: Week 50
Observed overall mean of 8-point PG profile after 50 weeks of treatment (visit 32)
Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 12, 2010

First Posted (Estimate)

February 15, 2010

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

November 23, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INS-3782
  • U1111-1112-6407 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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