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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: biphasic insulin aspart 30 Drug: metformin Drug: glimepiride Drug: insulin glargine
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT01123980
First Received	May 13, 2010
Last Updated	July 19, 2012
Last verified	July 2012

Tracking Information[ + expand ][ + ]

First Received Date	May 13, 2010
Last Updated Date	July 19, 2012
Start Date	May 2010
Estimated Primary Completion Date	June 2011
Current Primary Outcome Measures	Change in Glycosylated Haemoglobin (HbA1c) [Time Frame: Week 0, week 24] [Designated as safety issue: No]
Current Secondary Outcome Measures	9-point Plasma Glucose Profiles [Time Frame: Week 24] [Designated as safety issue: No]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. Percentage of Subjects Achieving HbA1c Below 7.0% [Time Frame: Week 24] [Designated as safety issue: No]The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment Percentage of Subjects Achieving HbA1c Below or Equal to 6.5% [Time Frame: Week 24] [Designated as safety issue: No]The percentage of subjects achieving the treatment target for glycosylated haemoglobin A1c after 24 weeks of treatment Number of Hypoglycaemic Episodes - All [Time Frame: Weeks 0-24] [Designated as safety issue: No] Number of Hypoglycaemic Episodes - Severe and Minor [Time Frame: Weeks 0-24] [Designated as safety issue: No]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. Number of Hypoglycaemic Episodes [Time Frame: Weeks 0-24] [Designated as safety issue: No]All episodes classified into nocturnal (time of onset between 00:00 (included) and 05:59 (included)).

Descriptive Information[ + expand ][ + ]

Brief Title	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
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
Brief 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.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Diabetes 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. Drug: metformin China: Tablets, 500 mg. Min. 1500 mg/day. Japan: Tablets, 250 mg. Min 500 mg/day. Drug: glimepiride China: Tablets, 2 mg. Min. 4 mg/day. Japan: Tablets, 1 mg. Min. 4 mg/day. Drug: insulin glargine Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
Study Arm (s)	Experimental: BIAsp 30 0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride Active Comparator: Insulin glargine 0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	521
Estimated Completion Date	June 2011
Estimated Primary Completion Date	June 2011
Eligibility Criteria	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)
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China, Japan

Administrative Information[ + expand ][ + ]

NCT Number	NCT01123980
Other Study ID Numbers	BIASP-3756
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Louise Kvistgaard Novo Nordisk A/S
Verification Date	July 2012

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