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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
insulin detemir
insulin aspart
insulin NPH
human soluble insulin
metformin
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Insulin detemir / IAsp

insulin NPH

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
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
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
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
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
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.
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).
Change From Baseline in Fructosamine After Two Weeks of Treatment
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.

Full Information

First Posted
December 5, 2011
Last Updated
February 9, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01486966
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
Trial terminated prematurely due to slow recruitment.
Study Start Date
November 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin detemir / IAsp
Arm Type
Experimental
Arm Title
insulin NPH
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
insulin detemir
Intervention Description
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Intervention Description
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
Intervention Type
Drug
Intervention Name(s)
human soluble insulin
Intervention Description
Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
Intervention Type
Drug
Intervention Name(s)
metformin
Intervention Description
For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
Primary Outcome Measure Information:
Title
Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
Description
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.
Time Frame
Week 0, week 2
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
Description
The FPG referred to pre-breakfast plasma glucose.
Time Frame
Week 0, week 2
Title
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
Description
The mean 2hPPG was derived from the 8-point PG profile as the mean value of the available 120 minutes after each meal.
Time Frame
Week 0, week 2
Title
Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
Description
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.
Time Frame
Week 0, week 2
Title
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
Time Frame
Week 2
Title
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
Time Frame
Week 2
Title
Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
Description
FPG target was < 6.0 mmol / L, 2hPPG target was < 8.0 mmol / L.
Time Frame
Week 2
Title
Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
Description
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).
Time Frame
Week 2
Title
Change From Baseline in Fructosamine After Two Weeks of Treatment
Time Frame
Week 0, week 2
Title
Incidence of Hypoglycaemic Episodes
Description
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.
Time Frame
Weeks 0-2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400016
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214023
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330006
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200003
Country
China
Facility Name
Novo Nordisk Investigational Site
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China

12. IPD Sharing Statement

Citations:
Citation
Guo X, Li Q, Shi Y, Bu R, Liu J, Qu S, Gao Y. Efficacy and safety of insulin detemir plus insulin aspart versus NPH insulin plus human soluble insulin with or without metformin in Chinese type 2 diabetes. Chinese J Diabetes 2014; 22 (1)
Results Reference
result
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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