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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01486966
• Other study ID #: NN304-3954
• Secondary ID: U1111-1123-7088
• Status: Terminated
• Phase: Phase 4
• First received: December 5, 2011
• Last updated: August 26, 2015
• Start date: November 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2015
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.)

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:
• insulin detemir
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
• insulin aspart
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
• insulin NPH
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
• human soluble insulin
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
• metformin
For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment	Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.	Week 0, week 2	No
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment	The FPG referred to pre-breakfast plasma glucose.	Week 0, week 2	No
Secondary	Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment	The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.	Week 0, week 2	No
Secondary	Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment	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.	Week 0, week 2	No
Secondary	Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment		Week 2	No
Secondary	Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment		Week 2	No
Secondary	Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment	FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.	Week 2	No
Secondary	Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment	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).	Week 2	No
Secondary	Change From Baseline in Fructosamine After Two Weeks of Treatment		Week 0, week 2	No
Secondary	Incidence of Hypoglycaemic Episodes	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.	Weeks 0-2	No

External Links

•   Clinical Trials at Novo Nordisk