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DiabetesPhase 2NCT01511198

Efficacy and Safety of Metformin and Liraglutide in Obese Subjects With Type 2 Diabetes Previously Treated With an Oral Hypoglycemic Agent

A Phase 2 study testing liraglutide and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in United States.

Completed

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

Official record
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Trial summary

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 2
What is being tested?
liraglutide and metformin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
223 participants
Where
39 sitesUnited States
Study dates
Feb 2001to Oct 2001
Phase
Phase 2
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Type 2 diabetic
  • Treated with OHA (oral hypoglycaemic agent monotherapy for at least 3 months. Prior use of metformin is allowed
  • Body Mass Index (BMI) between 27.0-42.0 kg/m^2 (inclusive)
  • HbA1c maximum 10% based on analysis from central laboratory

Who cannot join

  • Cardiac problems
  • Uncontrolled treated/untreated hypertension
  • Proliferative retinopathy or known autonomic neuropathy
  • Recurrent severe hypoglycemia as judged by the investigator
  • Known or suspected allergy to trial product or related products
  • Use of any drug (except for OHAs), which in the investigators opinion could interfere with the glucose level or body weight or any contraindication to metformin use or intolerance to metformin 1000 mg (prior to trial entry or during run-in period). Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed
Show all 10Show fewer
  • Known or suspected abuse of alcohol or narcotics
  • Current treatment with thiazolidinediones or chronic daily use of insulin (more than 7 days) within three months in the absence of intercurrent illness
  • TSH (thyroid stimulating hormone) below 0.2 or above 15 U/mL
  • Type 1 or other specific causes of diabetes

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

United States39 sites

  • Novo Nordisk Investigational Site

    Alhambra, California, 91801

  • Novo Nordisk Investigational Site

    Carlisle, Arkansas, 72024

  • Novo Nordisk Investigational Site

    Charleston, West Virginia, 25301

  • Novo Nordisk Investigational Site

    Charlotte, North Carolina, 28277

  • Novo Nordisk Investigational Site

    Chattanooga, Tennessee, 37404

  • Novo Nordisk Investigational Site

    Chicago, Illinois, 60607

  • Novo Nordisk Investigational Site

    Corpus Christi, Texas, 78404

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75230

  • Novo Nordisk Investigational Site

    Dallas, Texas, 75246

  • Novo Nordisk Investigational Site

    Duluth, Minnesota, 55805

  • Novo Nordisk Investigational Site

    Durham, North Carolina, 27710

  • Novo Nordisk Investigational Site

    Edmonds, Washington, 98026-7610

  • Novo Nordisk Investigational Site

    Edmonds, Washington, 98026

  • Novo Nordisk Investigational Site

    Jacksonville, Florida, 32216

  • Novo Nordisk Investigational Site

    Jonesboro, Arkansas, 72401

  • Novo Nordisk Investigational Site

    Melbourne, Florida, 32901

  • Novo Nordisk Investigational Site

    Miami, Florida, 33156

  • Novo Nordisk Investigational Site

    Mission Viejo, California, 92691

  • Novo Nordisk Investigational Site

    North Plainfield, New Jersey, 07060

  • Novo Nordisk Investigational Site

    Ocala, Florida, 34471

  • Novo Nordisk Investigational Site

    Oklahoma City, Oklahoma, 73104

  • Novo Nordisk Investigational Site

    Pembroke Pines, Florida, 33024

  • Novo Nordisk Investigational Site

    Renton, Washington, 98057

  • Novo Nordisk Investigational Site

    Richmond, Virginia, 23294

  • Novo Nordisk Investigational Site

    Salt Lake City, Utah, 84132

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78209

  • Novo Nordisk Investigational Site

    San Antonio, Texas, 78229

  • Novo Nordisk Investigational Site

    Springfield, Illinois, 62711

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63117

  • Novo Nordisk Investigational Site

    St Louis, Missouri, 63141

  • Novo Nordisk Investigational Site

    St. Petersburg, Florida, 33702

  • Novo Nordisk Investigational Site

    Tacoma, Washington, 98405

  • Novo Nordisk Investigational Site

    Titusville, Florida, 32796

  • Novo Nordisk Investigational Site

    Trumbull, Connecticut, 06611

  • Novo Nordisk Investigational Site

    Tucson, Arizona, 85719

  • Novo Nordisk Investigational Site

    Vestavia Hills, Alabama, 35209

  • Novo Nordisk Investigational Site

    Walnut Creek, California, 94598

  • Novo Nordisk Investigational Site

    West Palm Beach, Florida, 33401

  • Novo Nordisk Investigational Site

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: NNC 90-1170 Dose-response, Efficacy and Safety: A 12-week Randomized, Multicenter, Doubleblind, Double-dummy, Parallel-group Study of Metformin and Five Doses of NNC 90-1170 in Previously-treated OHA Monotherapy Obese Subjects With Type 2 Diabetes

This trial is conducted in the United States of America (USA). The aim of this trial is to determine the dose-response relationship for body weight and five escalating doses of NNC 90-1170 (liraglutide) in subjects with type 2 diabetes previously treated with an oral hypoglycemic agent (OHA).

Being tested
liraglutide, 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.

  • liraglutideDrug

    Also called NNC 90-1170

    Injected subcutaneously once daily

  • metforminDrug

    1000 mg twice daily, administered orally

Study groups in NCT01511198
Study groupRoleWhat they receive
0.045 mgExperimentalNot described
Receives: Drug: liraglutide
0.225 mgExperimentalNot described
Receives: Drug: liraglutide
0.45 mgExperimentalNot described
Receives: Drug: liraglutide
0.60 mgExperimentalNot described
Receives: Drug: liraglutide
0.75 mgExperimentalNot described
Receives: Drug: liraglutide
MetActive comparatorNot described
Receives: Drug: metformin

What is being measured

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

  1. Body weight

Secondary outcomes (5)

  1. FPG (fasting plasma glucose)

  2. HbA1c (glycosylated haemoglobin)

  3. Fructosamine

  4. Lipids

  5. Adverse events

Timeline

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

  1. First posted18 Jan 2012 (estimated)
  2. Study startFeb 2001
  3. Primary completionOct 2001
  4. Study completionOct 2001

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
223 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01511198
Sponsor's protocol ID
NN2211-2072
Status last verified
Jan 2017
First submitted
12 Jan 2012
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
No

Publications

  • Feinglos MN, Saad MF, Pi-Sunyer FX, An B, Santiago O; Liraglutide Dose-Response Study Group. Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes. Diabet Med. 2005 Aug;22(8):1016-23. doi: 10.1111/j.1464-5491.2005.01567.x.

    PubMed 16026367

  • Jensen TM, Saha K, Steinberg WM. Is there a link between liraglutide and pancreatitis? A post hoc review of pooled and patient-level data from completed liraglutide type 2 diabetes clinical trials. Diabetes Care. 2015 Jun;38(6):1058-66. doi: 10.2337/dc13-1210. Epub 2014 Dec 12.

    PubMed 25504028

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing liraglutide and metformin in people with Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 39 sites in United States.

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 4 inclusion and 10 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 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Body weight. 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 NCT01511198, which also lists 2 linked publications.

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 26 Jan 2017.

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