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

NCT ID: NCT01068652

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 403 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2012-05-31

Brief 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

Diabetes; Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

insulin detemir

Intervention Type: DRUG

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

insulin aspart

Intervention Type: DRUG

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)

metformin

Intervention Type: DRUG

1000-2000 mg/day in combination with insulin treatment

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.

Group Type: ACTIVE_COMPARATOR

biphasic insulin aspart 30

Intervention Type: DRUG

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

metformin

Intervention Type: DRUG

1000-2000 mg/day in combination with insulin treatment

Interventions

insulin detemir

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

Intervention Type: 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)

Intervention Type: 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

Intervention Type: DRUG

metformin

1000-2000 mg/day in combination with insulin treatment

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Ain Témouchent, , Algeria

Novo Nordisk Investigational Site

Algiers, , Algeria

Novo Nordisk Investigational Site

Constantine, , Algeria

Novo Nordisk Investigational Site

Oran, , Algeria

Novo Nordisk Investigational Site

Sétif, , Algeria

Novo Nordisk Investigational Site

Sidi Bel Abbes, , Algeria

Novo Nordisk Investigational Site

Alexandria, , Egypt

Novo Nordisk Investigational Site

Casablanca, , Morocco

Novo Nordisk Investigational Site

Port Elizabeth, Eastern Cape, South Africa

Novo Nordisk Investigational Site

Johannesburg, Gauteng, South Africa

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Novo Nordisk Investigational Site

Pretoria, Gauteng, South Africa

Novo Nordisk Investigational Site

Vaderbijlpark, Gauteng, South Africa

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Novo Nordisk Investigational Site

Durban, KwaZulu-Natal, South Africa

Novo Nordisk Investigational Site

Kimberly, Northern Cape, South Africa

Novo Nordisk Investigational Site

Cape Town, Western Cape, South Africa

Novo Nordisk Investigational Site

Sandton, , South Africa

Novo Nordisk Investigational Site

Tunisia, , Tunisia

Countries

Algeria; Egypt; Morocco; South Africa; Tunisia

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

U1111-1112-6407

Identifier Type: OTHER

Identifier Source: secondary_id

INS-3782

Identifier Type: -

Identifier Source: org_study_id