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CompletedNCT01753362Updated Dec 17, 2019Results posted

Liraglutide In Overweight Patients With Type 1 Diabetes

A Phase 3 interventional study of liraglutide and placebo in Type 1 Diabetes, sponsored by University at Buffalo. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-12-17.

Sponsored by University at Buffalo · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.

02

Conditions studied

03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 84 is close to the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

University at Buffalo is the lead sponsor of 73 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be \<30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)

Exclusion criteria

Exclusion Criteria:

1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase > 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR \<30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
84 participants (actual)

Study arms

  • Placebo comparator
    placebo

    subcutaneous daily injection

    Drug: placebo

  • Active comparator
    liraglutide

    subcutaneous daily injection

    Drug: liraglutide

Interventions

  • Drugliraglutide
  • Drugplacebo
06

What researchers measure

Primary outcomes

  1. HbA1c

    The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.

    Time frame: 26 weeks

Secondary outcomes

  1. Glucose Concentrations

    Mean daily glucose concentrations at baseline and 26 weeks

    Time frame: 26 weeks

07

Results

Posted Dec 17, 2019

Participant flow

Participant flow — Overall Study
MilestonePlaceboLiraglutide
Started3648
Completed2640
Not completed108

Outcome measures

PrimaryHbA1c

The primary endpoint of the study is to detect a difference in HbA1c percent at baseline and after 26 weeks of treatment with Liraglutide or placebo.

Time frame:
26 weeks
Reported as:
Mean · percent
HbA1c
percentPlaceboLiraglutide
baseline7.77 ± 0.837.94 ± 1.05
26 week7.64 ± 0.847.60 ± 0.98
SecondaryGlucose Concentrations

Mean daily glucose concentrations at baseline and 26 weeks

Time frame:
26 weeks
Reported as:
Mean · mg/dL
Glucose Concentrations
mg/dLPlaceboLiraglutide
baseline183 ± 6173 ± 8
26 week172 ± 5171 ± 9

Adverse events

Collected over 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo0/26 (0%)0/26 (0%)0/26 (0%)
Liraglutide0/40 (0%)0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)PlaceboLiraglutideTotal
<=18 years000
Between 18 and 65 years223658
>=65 years448
Age, Continuous
Age, Continuous(years)PlaceboLiraglutideTotal
Mean47 ± 14.647 ± 13.047 ± 8.0
Sex: Female, Male
Sex: Female, Male(Participants)PlaceboLiraglutideTotal
Female162642
Male101424
Race (NIH/OMB)
Race (NIH/OMB)(Participants)PlaceboLiraglutideTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American325
White233861
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)PlaceboLiraglutideTotal
United States264066
08

Study locations

2 sites
  • diabetes endocrinology center of WNY
    Buffalo, New York 14215, United States
  • Diabetes Endocrinology Research Center of WNY
    Buffalo, New York 14215, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Oct 2, 2018

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 17, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01753362
Lead sponsor
University at Buffalo
Collaborators
Juvenile Diabetes Research Foundation
Responsible party
Paresh Dandona (MD, University at Buffalo) — Principal investigator
First posted
Dec 20, 2012
Start date
Dec 2012
Primary completion
Dec 2017
Completion
Feb 2018
Results posted
Dec 17, 2019
Last update
Dec 17, 2019

Study contacts

Paresh Dandona, MBBS
principal investigator · SUNY UB

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

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