Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been terminated.
(Trial terminated prematurely due to slow recruitment.)
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01486966
First received: December 5, 2011
Last updated: June 27, 2013
Last verified: June 2013
  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 Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
Drug: insulin detemir
Drug: insulin aspart
Drug: insulin NPH
Drug: human soluble insulin
Drug: metformin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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.


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.



Enrollment: 58
Study Start Date: November 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Insulin detemir / IAsp 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: metformin
For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
Active Comparator: insulin NPH 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486966

Locations
China, Beijing
Beijing, Beijing, China, 100034
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Lili Pan Novo Nordisk China
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01486966     History of Changes
Other Study ID Numbers: NN304-3954, U1111-1123-7088
Study First Received: December 5, 2011
Results First Received: April 22, 2013
Last Updated: June 27, 2013
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin Aspart
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Isophane insulin, beef
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014