AzTrials
AzTrials

Type 1 DiabetesPhase 3NCT01722227

Anti-diabetic Effects of Liraglutide in Adolescents and Young Subjects With Type 1 Diabetes

A Phase 3 study testing Liraglutide in people with Type 1 Diabetes, run by University at Buffalo at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Read more about this study

Who is it for?
Ages 15 to 30 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Nov 2012to May 2018
Phase
Phase 3
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 15 to 30 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Females and males with Type 1 diabetes as ascertained by islet autoantibodies (GAD-65 and/or islet cell antibodies)
  • Age 15-30 years - This age group is being chosen as most will have completed puberty with the accompanying physiologic phase of increased insulin resistance. In addition, this age group shows increased self-management capabilities. Extending the age up to 30 years will allow us to include young adults, since type 1 diabetes is frequently diagnosed in the late teen and early adult years. This study is not powered to detect differences in liraglutide efficacy in different age group but it may provide insight into the effectiveness in the teenage population, in whom optimal glycemic control is often a challenge.
  • Type 1 diabetes duration greater than 1 year to ensure that a majority of subjects are beyond the partial remission period.
  • Fasting C-peptide level ≤ 0.3 ng/ml.
  • HbA1c level equal or less than 9%
  • Insulin delivery by CSII - the choice is made to facilitate adherence to study drug and also to enable us have a homogeneous group to analyze without having to analyze the data for the covariants of CSII vs. multiple daily injection therapy.
Show all 9Show fewer
  • Subjects willing to wear a CGM sensor and perform home blood glucose monitoring four times daily and with symptoms of hypoglycemia.
  • Subjects well-versed in carbohydrate counting.
  • BMI < 95th% for age and gender.

Who cannot join

  • Previous exposure to liraglutide
  • History of abdominal surgery
  • History of gastroparesis or gastrointestinal reflux disease;
  • History of acute or chronic pancreatitis
  • Cirrhosis or hepatic disease defined as transaminases levels > 3 times normal
  • Impaired renal function defined as serum creatinine >1.5.
Show all 18Show fewer
  • HIV or Hepatitis C positive status
  • Pregnant/breastfeeding females
  • Individuals with steroid-induced or cystic fibrosis related diabetes
  • Diabetic Ketoacidosis within 6 months of the study
  • History of severe hypoglycemia (seizure, loss of consciousness) within 6 months of the study
  • History of medullary thyroid cancer or MEN2 syndrome
  • Any other life-threatening cardiac or non-cardiac disease
  • Participation in a concurrent clinical trial or participation in a trial within 30 days preceding the study period.
  • Unable to give informed consent/assent.
  • Adolescents and adults who are considered underweight based on body mass index (BMI):
  • For adolescents: BMI less than the 5th percentile
  • For adults: BMI below 18.5

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diabetes-Endocrinology Center of WNY

    Williamsville, New York, 14221

Other trials in United States

About this study

This is the first prospective randomized double-blind placebo-controlled study to investigate the effect of a GLP-1 analog, specifically liraglutide, on blood glucose levels and variability in subjects with type 1 diabetes treated with insulin. Liraglutide is the preferred GLP-1 analog for this study because the pharmacokinetics and pharmacodynamics of the drug are consistent with a sustained duration of action. The current gold standard for management of type 1 diabetes is based on insulin replacement with novel analogs with specified pharmacodynamic profiles or with unique insulin delivery systems (insulin pump therapy). No other adjuvant therapy has demonstrated sustained benefit in this population. This study will also investigate the effect of liraglutide on suppression of glucagon secretion during meal challenges. This is of particular importance since, in the absence of insulin secretion from the β-cell, there is no paracrine inhibition of glucagon secretion by the α-cell. Dysregulation of glucagon secretion may impact the glycemic control and overall pathogenesis in those with type 1 diabetes. The use of CGM technology in this study will allow us to determine the rapidity, consistency, and sustainability of any response to liraglutide.

Conditions
Type 1 Diabetes
Being tested
Liraglutide, Placebo
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

Study groups in NCT01722227
Study groupRoleWhat they receive
Liraglutide 0.6mgActive comparatorDaily Injection
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorDaily Injection
Receives: Drug: Placebo

What is being measured

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

  1. Mean weekly blood glucose concentrations.

    The primary endpoint of the study is to detect a difference between Liraglutide and placebo groups in the change from baseline in mean weekly blood glucose concentrations after 12 weeks of treatment.

    Measured: 3 Months

Secondary outcomes (1)

  1. HbA1c

    Measured: 3 Months

Timeline

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

  1. First posted6 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionNov 2017 (estimated)
  4. Study completionMay 2018 (estimated)

Why it stopped: No Funding Received from ADA

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722227
Sponsor's protocol ID
1964 Liraglutide ADA
Other IDs
1-12-CT-20
Status last verified
Feb 2017
First submitted
2 Nov 2012
Last updated
9 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide in people with Type 1 Diabetes, run by University at Buffalo at 1 site 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 9 inclusion and 18 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: withdrawn, as of the sponsor's last update on 9 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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. Some participants in this study may receive a placebo. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Mean weekly blood glucose concentrations. (time frame: 3 Months). 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 NCT01722227.

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 9 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in