DiabetesPhase 4NCT01486966

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 Phase 4 study testing insulin detemir, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetes, Diabetes Mellitus, Type 2
What is being tested?: insulin detemir, insulin aspart and insulin NPH
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 6 sitesChina
Study dates: Nov 2011to Jun 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

China6 sites

Novo Nordisk Investigational Site
Beijing, Beijing Municipality, 100034
Novo Nordisk Investigational Site
Chongqing, Chongqing Municipality, 400016
Novo Nordisk Investigational Site
Nanchang, Jiangxi, 330006
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200003
Novo Nordisk Investigational Site
Shanghai, Shanghai Municipality, 200072
Novo Nordisk Investigational Site
Wuxi, Jiangsu, 214023

Other trials in China

About this study

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

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.

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, insulin aspart, insulin NPH, human soluble insulin, metformin
Medical subject headings: Diabetes Mellitus, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT01486966
Study group	Role	What they receive
Insulin detemir / IAsp	Experimental	Not described Receives: Drug: insulin detemir; Drug: insulin aspart; Drug: metformin
insulin NPH	Active comparator	Not described Receives: Drug: insulin NPH; Drug: human soluble insulin; Drug: metformin

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 0, week 2

Secondary outcomes (9)

Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
The FPG referred to pre-breakfast plasma glucose.
Measured: Week 0, week 2
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.
Measured: Week 0, week 2
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.
Measured: Week 0, week 2
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
Measured: Week 2
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
Measured: Week 2
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.
Measured: Week 2
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).
Measured: Week 2
Change From Baseline in Fructosamine After Two Weeks of Treatment
Measured: Week 0, week 2
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.
Measured: Weeks 0-2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Jun 2012

First posted7 Dec 2011 (estimated)
Study startNov 2011
Primary completionJun 2012
Study completionJun 2012

Why it stopped: Trial terminated prematurely due to slow recruitment.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for DiabetesStudies of the same condition, open and under way.
More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01486966
Sponsor's protocol ID: NN304-3954
Other IDs: U1111-1123-7088
Status last verified: Feb 2017
First submitted: 5 Dec 2011
Last updated: 17 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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)

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01486966
Acronym / sponsor ID: NN304-3954
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Trial terminated prematurely due to slow recruitment.
Enrolment: 58 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2011
Primary completion: Jun 2012 (actual)
Study completion: Jun 2012 (actual)
First posted: 7 Dec 2011 (estimated)
Results: Posted 17 Jun 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Insulin detemir / IAsp	Experimental	Drug: insulin detemir, Drug: insulin aspart, Drug: metformin
insulin NPH	Active comparator	Drug: insulin NPH, Drug: human soluble insulin, Drug: metformin

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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.)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
insulin detemirDose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4	Drug	Insulin detemir / IAsp
insulin aspartDose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4	Drug	Insulin detemir / IAsp
insulin NPHDose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4	Drug	insulin NPH
human soluble insulinDose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4	Drug	insulin NPH
metforminFor subjects previously treated with metformin, the dosage and frequency will be kept unchanged	Drug	Insulin detemir / IAsp, insulin NPH

Primary outcome

Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment
Time frame: Week 0, week 2
Mean value of 8-point PG was the arithmetic mean of all 8 time-instant PG values of the 8-point PG profile.

9 secondary outcomes

Change From Baseline in Fasting Plasma Glucose (FPG) After Two Weeks of Treatment
Time frame: Week 0, week 2
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
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
Percentage of Subjects Achieving FPG < 6.0 mmol / L After Two Weeks of Treatment
Time frame: Week 2
Percentage of Subjects Achieving Mean 2hPPG of 3 Meals < 8.0 mmol / L After Two Weeks of Treatment
Time frame: Week 2
Percentage of Subjects Achieving Both FPG and 2hPPG Targets After Two Weeks of Treatment
Time frame: Week 2
Percentage of Subjects Achieving FPG Target Without Nocturnal Hypoglycaemia After Two Weeks of Treatment
Time frame: Week 2
Change From Baseline in Fructosamine After Two Weeks of Treatment
Time frame: Week 0, week 2
Incidence of Hypoglycaemic Episodes
Time frame: Weeks 0-2

Results and safety

Results posted to the registry on 17 Jun 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Insulin Detemir + Insulin Aspart ± Metformin	29	29
Insulin NPH + Human Soluble Insulin ± Metformin	29	27

Primary outcome: Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment

Time frame: Week 0, week 2. Least squares mean (Standard Error). Unit: mmol/L

Measure	Insulin Detemir + Insulin Aspart ± Metformin n = 29	Insulin NPH + Human Soluble Insulin ± Metformin n = 27
Value	-2.84 (0.27)	-2.80 (0.28)

Population analysed: Full analysis set using LOCF (Last Observation Carried Forward) included all randomised subject. The 2 subjects who withdrew after randomisation were excluded from the efficacy analyses.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: The adverse events were collected in a timeframe of 2 weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Insulin Detemir + Insulin Aspart ± Metformin	0 of 29 (0%)	0 of 29 (0%)	Not reported
Insulin NPH + Human Soluble Insulin ± Metformin	0 of 29 (0%)	2 of 29 (6.9%)	Not reported

Limitations and caveats (from the sponsor): The size of population analysed in study was smaller than that planned in the protocol. Therefore, the superiority of experimental products to comparator could not be concluded with sufficient statistical power.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publicationGuo 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)
Clinical Trials at Novo NordiskLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Global Clinical Registry (GCR, 1452) study director

Novo Nordisk A/S

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing insulin detemir, insulin aspart and insulin NPH in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Mean 8-point Plasma Glucose (PG) After Two Weeks of Treatment (time frame: Week 0, week 2). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01486966, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.