Effect of Biphasic Insulin Aspart 30 Combined With Metformin on Blood Glucose Control in Subjects With Type 2 Diabetes Inadequately Controlled With Basal Insulin

NCT00669864 | Completed Phase 4 Results

• 1 other identifier: BIASP-1960
• Study Type: interventional
• Target: 293
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is conducted in Asia. This single arm trial aims to evaluate the blood glucose control with twice daily biphasic insulin aspart 30 in combination with metformin in Chinese subjects with type 2 diabetes inadequately controlled with once or twice daily basal insulin.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (Glycosylated Haemoglobin A1c)

  Change in Glycosylated Haemoglobin A1c (HbA1c) from baseline (week 0) to 16 weeks (end of treatment)

  week 0, week 16

Secondary Outcomes (5)

• Change in 8-point Plasma Glucose Profile

  week 0, week 16

• Percentage of Subjects Achieving HbA1c Less Than 7.0%

  week 16

• Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%

  week 16

• Hypoglycaemic Episodes

  weeks 0-16

• Hypoglycaemic Episodes, Diurnal/Nocturnal

  weeks 0-16

Study Arms (1)

BIAsp 30-30

EXPERIMENTAL

Individual adjusted dose of biphasic insulin aspart 30 administered before breakfast and dinner in combination with metformin 1000-2000mg, up to three times daily

Drug: biphasic insulin aspart 30; Drug: metformin

Interventions

biphasic insulin aspart 30 DRUG

Subcutaneous (under the skin) injection, twice daily

Also known as: NovoMix® 30

BIAsp 30-30

metformin DRUG

Tablets, 1000 - 2000 mg daily

BIAsp 30-30

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes
• Currently treated with basal insulin once or twice daily with or without oral anti-diabetic drugs (OADs) for at least 3 months
• HbA1c (glycosylated haemoglobin A1c) within the range of 7.5% to10.0% ( both inclusive)
• BMI (Body Mass Index) maximum 40 kg/m2

You may not qualify if:

• Metformin contraindications according to local practice
• Systemically treated with TZDs (thiazolidinediones) for more than one month within 6 months prior to this trial

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Unknown Facility

Beijing, Beijing Municipality, 100034, China

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70; Metformin

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Limitations and Caveats

This single-armed trial does not permit a comprehensive comparison between BIAsp30 and basal insulin. Otherwise, this could have proffered greater clarity on the putative benefits that BIAsp30 brings to subjects with type 2 diabetes.

Results Point of Contact

• Title: Public Access to Clinical Trials
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2008
• First Posted: May 1, 2008
• Study Start: November 1, 2007
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 1, 2016
• Results First Posted: July 5, 2010

Record last verified: 2016-03

Locations

CN (1)