NCT01486966|TerminatedPhase 4Results

Study Stopped

Trial terminated prematurely due to slow recruitment.

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

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

Novo Nordisk A/S ClinicalTrials.gov

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2 other identifiers

NN304-3954U1111-1123-7088

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredDec 2011

StartedNov 2011

CompletionJun 2012

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline

Completed

Started Nov 2011

Shorter than P25 for phase_4 diabetes

Geographic Reach

1 country

6 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7 months study duration

Study Start

First participant enrolled

November 1, 2011

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

December 5, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2011

Completed

6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed

1 year until next milestone

Results Posted

Study results publicly available

June 17, 2013

Completed

Last Updated

March 17, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

December 5, 2011

Results QC Date

April 22, 2013

Last Update Submit

February 9, 2017

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
Week 0, week 2
Change From Baseline in Mean 2-hour Post Prandial Plasma Glucose (2hPPG) of 3 Meals After Two Weeks of Treatment
Week 0, week 2
Change From Baseline in Mean Value of Pre-lunch, Pre-dinner and Bedtime PG After Two Weeks of Treatment
Week 0, week 2
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
Week 2
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
Week 2
+4 more secondary outcomes

Study Arms (2)

Insulin detemir / IAsp

EXPERIMENTAL

Drug: insulin detemirDrug: insulin aspartDrug: metformin

insulin NPH

ACTIVE COMPARATOR

Drug: insulin NPHDrug: human soluble insulinDrug: metformin

Interventions

insulin detemirDRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

Insulin detemir / IAsp

insulin aspartDRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

Insulin detemir / IAsp

insulin NPHDRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4

insulin NPH

human soluble insulinDRUG

Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4

insulin NPH

metforminDRUG

For subjects previously treated with metformin, the dosage and frequency will be kept unchanged

Insulin detemir / IAspinsulin NPH

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.)

Contact the study team to confirm eligibility.