Comparison of the Blood Sugar Lowering Effect of Biphasic Insulin Aspart 30 and Insulin Glargine Both Combined With Metformin and Glimepiride in Chinese and Japanese Subjects With Type 2 Diabetes New to Insulin Treatment

Diabetes Mellitus, Type 2 Clinical Trial

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Official title:

An Open-labelled, Randomised, Parallel Group, 3 Week run-in and 24 Week Treat-to-target Comparison of Biphasic Insulin Aspart 30 Once Daily Versus Insulin Glargine Once Daily Both in Combination With Metformin and Glimepiride in Chinese and Japanese Insulin Naive Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01123980
• Other study ID #: BIASP-3756
• Secondary ID: U1111-1114-4112J
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2010
• Last updated: October 22, 2014
• Start date: May 2010
• Est. completion date: June 2011

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug AdministrationJapan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect of biphasic insulin aspart 30 once daily compared to insulin glargine once daily both in combination with metformin and glimepiride in Chinese and Japanese subjects with type 2 diabetes who have never received insulin before.

The trial is conducted as a phase 4 trial in China and phase 3 in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Type 2 diabetes treated with a maximum of three different types of oral anti-diabetic drugs (OADs) (including traditional Chinese medicine which contains active ingredients of known OADs) for more than 6 months

• Unchanged total daily dose of at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) metformin for the last two months

• Unchanged total daily dose of at least half maximum recommended total daily dose of any insulin secretagogue for the last two months

• Insulin naive

• HbA1c between 7.0% and 10.0%

• FPG (fasting plasma glucose) equal to or above 6.1 mmol/L (110mg/dL)

• Body Mass Index (BMI) below 40.0 kg/m^2

Exclusion Criteria:

• Treatment with any thiazolidinedione (TZD) and GLP-1 (glucagon like peptide-1) receptor antagonists during the last 3 months before Visit 1 in this trial

• Any disease or condition which the Investigator feels would interfere with the trial

• Any contraindication to metformin or glimepiride (according to local labelling)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• biphasic insulin aspart 30
Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
• metformin
China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day.
• glimepiride
China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day.
• insulin glargine
Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

China,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glycosylated Haemoglobin (HbA1c)		Week 0, week 24	No
Secondary	9-point Plasma Glucose Profiles	Glycaemic control measured by 9-point plasma glucose (SPMG) profiles. The 9 timepoints for self-measurement during the day were: before breakfast, 2 hours after breakfast, before lunch, 2 hours after lunch, before dinner, 2 hours after dinner, before bedtime, at 2-4 a.m. and before breakfast the following day.	Week 24	No
Secondary	Percentage of Subjects Achieving HbA1c Below 7.0%	The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment	Week 24	No
Secondary	Percentage of Subjects Achieving HbA1c Below or Equal to 6.5%	The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment	Week 24	No
Secondary	Number of Hypoglycaemic Episodes - All		Weeks 0-24	No
Secondary	Number of Hypoglycaemic Episodes - Severe and Minor	Hypoglycaemic episodes (hypos) summarised based on American Diabetes Association classification (severe, documented symptomatic, asymptomatic, probable symptomatic, and relative hypoglycaemia) and according to additional definition (minor hypoglycaemia). Severe hypos: requiring another person to actively administer resuscitative actions. Minor hypos: symptoms with plasma glucose below 3.1 mmol/L (56 mg/dl), or any asympomatic plasma glucose below 3.1 mmol/L.	Weeks 0-24	No
Secondary	Number of Hypoglycaemic Episodes	All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).	Weeks 0-24	No

External Links

•   Clinical Trials at Novo Nordisk