Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes | RxWiki

Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes

Overview[ - collapse ][ - ]

Purpose	This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes. The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.
Condition	Diabetes Diabetes Mellitus, Type 2
Intervention	Drug: insulin detemir Drug: insulin aspart Drug: insulin NPH Drug: human soluble insulin Drug: metformin
Phase	Phase 4
Sponsor	Novo Nordisk A/S
Responsible Party	Novo Nordisk A/S
ClinicalTrials.gov Identifier	NCT01486966
First Received	December 5, 2011
Last Updated	June 27, 2013
Last verified	June 2013

Tracking Information[ + expand ][ + ]

First Received Date	December 5, 2011
Last Updated Date	June 27, 2013
Start Date	November 2011
Estimated Primary Completion Date	June 2012
Current Primary Outcome Measures	Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment [Time Frame: Week 0, week 2] [Designated as safety issue: No]Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
Current Secondary Outcome Measures	Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment [Time Frame: Week 0, week 2] [Designated as safety issue: No]The FPG referred to pre-breakfast plasma glucose. Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment [Time Frame: Week 0, week 2] [Designated as safety issue: No]The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal. Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment [Time Frame: Week 0, week 2] [Designated as safety issue: No]The mean value of pre-lunch, pre-dinner and bedtime PG was derived from the 8-point PG profile measured before lunch, dinner and bedtime. Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment [Time Frame: Week 2] [Designated as safety issue: No] Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment [Time Frame: Week 2] [Designated as safety issue: No] Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment [Time Frame: Week 2] [Designated as safety issue: No]FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L. Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment [Time Frame: Week 2] [Designated as safety issue: No]FPG target was < 6.0 mmol / L. Nocturnal hypoglycaemia was defined as a hypoglycaemic episode happened between 00:01 and 05:59 a.m. (both included). Change From Baseline in Fructosamine After Two Weeks of Treatment [Time Frame: Week 0, week 2] [Designated as safety issue: No] Incidence of Hypoglycaemic Episodes [Time Frame: Weeks 0-2] [Designated as safety issue: No]All events summarized were treatment emergent hypoglycaemic events. Hypoglycaemic episodes were summarized based on the ADA classification and also according to an additional definition. Severe hypoglycemia: ADA definition. Minor hypoglycaemic episode: an episode with symptoms with confirmation by plasma glucose (PG) < 3.1 mmol/l (56 mg/dl) and was handled by the subject himself/herself, or any asymptomatic PG value < 3.1 mmol/l (56 mg/dl). A hypoglycaemia episode was defined as nocturnal if the time of onset was between 00:01 and 05:59 a.m. (both included), otherwise it was diurnal.

Descriptive Information[ + expand ][ + ]

Brief Title	Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin With or Without Metformin in Chinese Patients With Type 2 Diabetes
Official Title	A 2-week, Randomised, Controlled, Open-label, Two-group Parallel, Multi-centre Trial Comparing Efficacy and Safety of Insulin Detemir Plus Insulin Aspart and NPH Insulin Plus Human Soluble Insulin Both in a Basal Bolus Regimen With or Without Metformin in Chinese Inpatients With Type 2 Diabetes Currently Treated With Insulin Qualifying for Intensified Treatment
Brief Summary	This trial is conducted in Asia. The aim of this trial is to compare efficacy and safety of insulin detemir plus insulin aspart and NPH insulin plus human soluble insulin both in a basal bolus regimen with or without metformin in Chinese patients with type 2 diabetes. The trial adopts a group sequential design, where the analysis of the primary efficacy endpoint will be performed at the interim analysis, in addition to the final formal analysis. The decision to continue or stop the trial will be based on the result of the interim analysis.
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: insulin detemir Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 Drug: insulin aspart Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 Drug: insulin NPH Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4 Drug: human soluble insulin Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4 Drug: metformin For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
Study Arm (s)	Experimental: Insulin detemir / IAsp Active Comparator: insulin NPH

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	58
Estimated Completion Date	June 2012
Estimated Primary Completion Date	June 2012
Eligibility Criteria	Inclusion Criteria: - Type 2 diabetes mellitus (diagnosed clinically) for at 12 months or longer - Currently treated with basal insulin once daily or premixed insulin twice daily for at least 3 months with or without OAD(s), and total daily insulin dose less than 1.4 IU (U)/kg (If treated with metformin, unchanged total daily dose of at least 1000 mg for at least 3 months) - Body Mass Index (BMI) equal to 40 kg/m^2 or below - HbA1c (glycosylated haemoglobin A1c) between 7.0% and 10.0% by central laboratory analysis - Plan to be admitted for optimising glycaemic control at least 2 days prior to the randomisation Exclusion Criteria: - Treatment with thiazolidinediones (TZD) or Glucagon-Like Peptide-1 (GLP-1) receptor agonists within the last 3 months prior to the screening - Anticipated change after the randomisation in concomitant medication known to interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers and mono amine oxidase (MAO) inhibitors - Previous participation in this trial (participation is defined as randomised. Re-screening of screening failures is allowed only once within the limits of the recruitment period.)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China

Administrative Information[ + expand ][ + ]

NCT Number	NCT01486966
Other Study ID Numbers	NN304-3954
Has Data Monitoring Committee	No
Information Provided By	Novo Nordisk A/S
Study Sponsor	Novo Nordisk A/S
Collaborators	Not Provided
Investigators	Study Director: Lili Pan Novo Nordisk China
Verification Date	June 2013

Locations[ + expand ][ + ]