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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT01511198 (opens ClinicalTrials.gov in a new tab)Other idNN2211-2072
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
223 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
1 country

United States

Start
Feb 2001
Primary completion
Oct 2001
Completion
Oct 2001
First posted
18 Jan 2012 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20012002
  1. Ph 2

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

    NCT01511198

    Feb 2001 to Oct 2001

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • metforminDrug

Arms6

  • Experimental

    0.045 mg

  • Experimental

    0.225 mg

  • Experimental

    0.45 mg

  • Experimental

    0.60 mg

  • Experimental

    0.75 mg

  • Active comparator

    Met

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Body weight

Secondary outcomes(5)

  1. FPG (fasting plasma glucose)

  2. HbA1c (glycosylated haemoglobin)

  3. Fructosamine

  4. Lipids

  5. Adverse events

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2005

10 results

Effects of liraglutide (NN2211), a long-acting GLP-1 analogue, on glycaemic control and bodyweight in subjects with Type 2 diabetes.

Feinglos et al. 2005Diabetic medicine : a journal of the British Diabetic Associationcited by 99

PMID 16026367DOI 10.1111/j.1464-5491.2005.01567.xPUB-16026367

Rights unknown10 results
Source linkSee results (10)

More studies

1 study on this page

Indexing hint: Meta-analysis (pooled) · 2015

Corrected

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.

Jensen et al. 2015Diabetes carecited by 45

PMID 25504028DOI 10.2337/dc13-1210PUB-25504028

Rights unknown
Source linkRead the notice

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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

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