DiabetesPhase 3NCT00789191

Effect of Detemir and Sitagliptin on Blood Glucose Control in Type 2 Diabetes

A Phase 3 study testing insulin detemir, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 51 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This trial is conducted in Asia, Europe and North America. This trial aims for comparison of the effect on the glycemic control in subjects with type 2 diabetes of basal insulin analogue with one oral anti-diabetic drug (OAD) versus oral anti-diabetic drug alone. 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, sitagliptin and metformin
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 222 participants
Where: 51 sitesin 8 countries
Study dates: Nov 2008to Aug 2009
Phase: Phase 3
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

Diagnosed with type 2 diabetes for at least 6 months before trial start
Treatment with at least 1000 mg metformin per day for at least 3 months
Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
DPP-4 (dipeptidyl peptidase-4) inhibitor naive
HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis
BMI (Body Mass Index) lesser than or equal to 45.0 kg/m2
Able and willing to take one subcutaneous injection every day
Able and willing to perform mandatory SMPG (self measured plasma glucose) measurements

Who cannot join

Known or suspected allergy or intolerance to any of the trial products or related products
Severe hypertension
Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
Cardiac disease, within the last 12 months
Impaired hepatic function
Impaired renal function

Show all 9Show fewer

Proliferative retinopathy or macular oedema requiring acute treatment
Female of childbearing potential
Known or suspected abuse of alcohol, narcotics or illicit substances

Trial locations and contacts

51 sites in 8 countries.

Country

City, postcode or hospital

51 sites in 8 countries

United States10 sites

Novo Nordisk Investigational Site
Chattanooga, Tennessee, 37411
Novo Nordisk Investigational Site
Cincinnati, Ohio, 45245
Novo Nordisk Investigational Site
Dallas, Texas, 75246
Novo Nordisk Investigational Site
Dayton, Ohio, 45439
Novo Nordisk Investigational Site
Dunwoody, Georgia, 30338
Novo Nordisk Investigational Site
Norristown, Pennsylvania, 19401
Novo Nordisk Investigational Site
Orange, California, 92869
Novo Nordisk Investigational Site
Santa Monica, California, 90404
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, 35209
Novo Nordisk Investigational Site
West Seneca, New York, 14224

Other trials in United States

Canada10 sites

Novo Nordisk Investigational Site
Cambridge, Ontario, N1R 7L6
Novo Nordisk Investigational Site
Coquitlam, British Columbia, V3K 3P4
Novo Nordisk Investigational Site
New Westminster, British Columbia, V3L 3W5
Novo Nordisk Investigational Site
Niagara Falls, Ontario, L2E 7H1
Novo Nordisk Investigational Site
Niagara Falls, L2G 5X7
Novo Nordisk Investigational Site
Saint Romuald, Quebec, G6W 5M6
Novo Nordisk Investigational Site
Sherbrooke, Quebec, J1H 4J6
Novo Nordisk Investigational Site
St. John's, Newfoundland and Labrador, A1A 3R5
Novo Nordisk Investigational Site
Toronto, Ontario, M3J 1N2
Novo Nordisk Investigational Site
Toronto, Ontario, M9W 4L6

Other trials in Canada

France7 sites

Novo Nordisk Investigational Site
Brest, 29200
Novo Nordisk Investigational Site
La Roche-sur-Yon, 85295
Novo Nordisk Investigational Site
Le Creusot, 71200
Novo Nordisk Investigational Site
Lille, 59037
Novo Nordisk Investigational Site
Montigny-lès-Metz, 57950
Novo Nordisk Investigational Site
Narbonne, 11108
Novo Nordisk Investigational Site
Roubaix, 59100

Other trials in France

Finland6 sites

Novo Nordisk Investigational Site
Helsinki, FI-00350
Novo Nordisk Investigational Site
Loimaa, FI-32200
Novo Nordisk Investigational Site
Oulu, FI-90220
Novo Nordisk Investigational Site
Pieksämäki, 76100
Novo Nordisk Investigational Site
Pori, FI-28100
Novo Nordisk Investigational Site
Seinäjoki, FI-60100

Other trials in Finland

Slovakia6 sites

Novo Nordisk Investigational Site
Bratislava, 831 01
Novo Nordisk Investigational Site
Bratislava, 851 01
Novo Nordisk Investigational Site
Košice, 040 01
Novo Nordisk Investigational Site
Lučenec, 98401
Novo Nordisk Investigational Site
Prešov, 080 01
Novo Nordisk Investigational Site
Žilina, 01001

Other trials in Slovakia

Hungary5 sites

Novo Nordisk Investigational Site
Budapest, 1083
Novo Nordisk Investigational Site
Budapest, 1125
Novo Nordisk Investigational Site
Budapest, H-1212
Novo Nordisk Investigational Site
Eger, 3300
Novo Nordisk Investigational Site
Pécs, 7623

Other trials in Hungary

Turkey (Türkiye)4 sites

Novo Nordisk Investigational Site
Ankara, 06100
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34390
Novo Nordisk Investigational Site
Kocaeli, 41380

Other trials in Turkey (Türkiye)

South Korea3 sites

Novo Nordisk Investigational Site
Daegu, 705-717
Novo Nordisk Investigational Site
Incheon, 400-103
Novo Nordisk Investigational Site
Seoul, 135-239

Other trials in South Korea

About this study

Official title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus

Conditions: Diabetes, Diabetes Mellitus, Type 2
Being tested: insulin detemir, sitagliptin, metformin, sulphonylurea
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
The detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.
sitagliptinDrug
The sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.
metforminDrug
Metformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.
sulphonylureaDrug
Sulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.

Study groups in NCT00789191
Study group	Role	What they receive
Comb	Experimental	Combination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment Receives: Drug: insulin detemir; Drug: sitagliptin; Drug: metformin
Sita	Active comparator	Monotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment Receives: Drug: sitagliptin; Drug: metformin; Drug: sulphonylurea

What is being measured

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

HbA1c (Glycosylated Haemoglobin A1c)
Measured: Week 26

Secondary outcomes (11)

Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Measured: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Measured: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Measured: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Symptomatic hypoglycaemia is biochemically confirmed hypoglycaemia or major hypoglycaemia
Measured: Week 26
Change in BMI (Body Mass Index)
Measured: Week 0, Week 26
Change in Body Weight
Measured: Week 0, Week 26
FPG (Fasting Plasma Glucose)
Measured: Week 26
Hypoglycemic Episodes
Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Measured: Weeks 0-26
Hypoglycemic Episodes: Day Time
Day time: Episodes between 6 pm and 11 am. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Measured: Weeks 0-26
Hypoglycemic Episodes: Night Time
Night time: Episodes between 11 am and 6 pm. Overall: All episodes. Minor: Symptomatic, with PG < 3.1 mmol/L. Symptoms only: Symptomatic with PG ≥ 3.1 mmol/L
Measured: Weeks 0-26
Self-measured 9-point Plasma Glucose Profile
Measured: Week 26

Timeline

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

Nov 2008Aug 2009

First posted11 Nov 2008 (estimated)
Study startNov 2008
Primary completionAug 2009
Study completionAug 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00789191
Sponsor's protocol ID: NN304-3511
Other IDs: 2008-001050-40, 2008
Status last verified: Feb 2017
First submitted: 10 Nov 2008
Last updated: 14 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.
PubMed 21205123

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Detemir and Sitagliptin on Blood Glucose Control in Subjects With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT00789191
Acronym / sponsor ID: NN304-3511
Conditions: Diabetes, Diabetes Mellitus, Type 2
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: Novo Nordisk A/SIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 11 Nov 2008 (estimated)
Results: Posted 10 Dec 2010

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
Comb	Experimental	Drug: insulin detemir, Drug: sitagliptin, Drug: metforminCombination therapy of insulin detemir once daily plus sitagliptin added to subject's own pre-trial metformin treatment
Sita	Active comparator	Drug: sitagliptin, Drug: metformin, Drug: sulphonylureaMonotherapy of sitagliptin once daily added to subject's own pre-trial metformin and/or sulphonylurea (SU) treatment

Who may qualify

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

Key inclusion criteria (8 listed)

Diagnosed with type 2 diabetes for at least 6 months before trial start
Treatment with at least 1000 mg metformin per day for at least 3 months
Insulin-naive (short-term insulin treatment of up to 14 days is allowed)
DPP-4 (dipeptidyl peptidase-4) inhibitor naive
HbA1c (glycosylated haemoglobin A1c) between 7.5-10.0% by central laboratory analysis

Key exclusion criteria (9 listed)

Known or suspected allergy or intolerance to any of the trial products or related products
Severe hypertension
Treatment with thiazolidinedione (TZD) or GLP-1 (glucagon-like peptide-1) analogues within 2 months prior to trial start
Cardiac disease, within the last 12 months
Impaired hepatic function

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 detemirThe detemir insulin dose is injected subcutaneously (under the skin) once daily in the evening and will be titrated (individually adjusted) weekly throughout the trial.	Drug	Comb
sitagliptinThe sitagliptin dose is 100 mg/ day and should be kept stable throughout the trial. Frequency of sitagliptin is once daily.	Drug	Comb, Sita
metforminMetformin treatment with at least 1000 mg/ day. Dose and dosing frequency should remain unchanged throughout the trial.	Drug	Comb, Sita
sulphonylureaSulphonylurea (SU) dose and dosing frequency should initially remain unchanged. In case of hypoglycaemia SU dose may be reduced at the discretion of the investigator.	Drug	Sita

Primary outcome

HbA1c (Glycosylated Haemoglobin A1c)
Time frame: Week 26

11 secondary outcomes

Number of Subjects Achieving HbA1c Less Than or Equal to 7.0%
Time frame: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 7.0% Without Symptomatic Hypoglycaemia
Time frame: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5%
Time frame: Week 26
Number of Subjects Achieving HbA1c Less Than or Equal to 6.5% Without Symptomatic Hypoglycaemia
Time frame: Week 26
Change in BMI (Body Mass Index)
Time frame: Week 0, Week 26
Change in Body Weight
Time frame: Week 0, Week 26
FPG (Fasting Plasma Glucose)
Time frame: Week 26
Hypoglycemic Episodes
Time frame: Weeks 0-26
Hypoglycemic Episodes: Day Time
Time frame: Weeks 0-26
Hypoglycemic Episodes: Night Time
Time frame: Weeks 0-26
Self-measured 9-point Plasma Glucose Profile
Time frame: Week 26

Results and safety

Results posted to the registry on 10 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Comb	111	97
Sita	111	92

Primary outcome: HbA1c (Glycosylated Haemoglobin A1c)

Time frame: Week 26. Mean (Standard Error). Unit: Percent (%) glycosylated haemoglobin

Measure	Comb n = 103	Sita n = 106
Value	7.08 (0.09)	7.64 (0.09)

Comb vs Sita: Mean Difference (Final Values): -0.55 (95% CI -0.77 to -0.33), p = 0.0010, ANCOVA

Population analysed: Sample size calculation: Assuming a standard deviation of 1.0 for HbA1c, 100 subjects in each treatment arm would be required to obtain a power of 80% for detecting a HbA1c difference of 0.4%. FAS (Full Analysis Set) is all randomised subjects exposed to at least one dose of trial product with a post baseline observation.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Weeks 0-26. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Comb	2 of 107 (1.9%)	76 of 107 (71%)	Not reported
Sita	4 of 110 (3.6%)	72 of 110 (65.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21205123Hollander P, Raslova K, Skjoth TV, Rastam J, Liutkus JF. Efficacy and safety of insulin detemir once daily in combination with sitagliptin and metformin: the TRANSITION randomized controlled trial. Diabetes Obes Metab. 2011 Mar;13(3):268-75. doi: 10.1111/j.1463-1326.2010.01351.x.
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

51 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing insulin detemir, sitagliptin and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 51 sites in 8 countries.

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 8 inclusion and 9 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: finished, as of the sponsor's last update on 14 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 51 sites in United States, Canada, France, Finland, Slovakia and 3 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 10 Dec 2010). 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?

HbA1c (Glycosylated Haemoglobin A1c) (time frame: Week 26). 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 NCT00789191, 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 14 Mar 2017.