A Phase 4 interventional study of Liraglutide and Metformin in Type 2 Diabetes, Overweight and Obesity, sponsored by University of Miami. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-06-06.
Sponsored by University of Miami · Phase 4, Interventional, and Treatment
The purpose of this research study is to learn about the effect of Liraglutide, (Victoza®), on the fat surrounding the heart.Excessive amount of the fat around the heart is common in people with type 2 diabetes and can be associated with poor sugar control. Liraglutide is an injectable prescription medicine that can improve blood sugar control in adults with type 2 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 100 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →University of Miami is the lead sponsor of 820 studies on the registry; 161 are open to participants now.
Of its 111 completed or terminated interventional studies of FDA-regulated products, 93 (84%) have results posted.
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Exclusion Criteria:
Known contra-indications to Liraglutide, such as previous history of pancreatitis or medullary thyroid carcinoma, personal or family history of MEN, in accordance with risks and safety information included in the latest updated Prescribing Information for Victoza®
• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued.
Drug: Liraglutide · Drug: Metformin
M-group will be treated with Metformin for the duration of the study. Metformin (from 500 mg twice daily to a maximum of 1000 mg twice daily) regimen will be continued to achieve fasting glucose between 80 and 140 mg/dl
Drug: Metformin
Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. .
Echocardiographic Epicardial Fat Thickness
Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
Time frame: 6 months
| Milestone | Liraglutide | Metformin |
|---|---|---|
| Started | 55 | 45 |
| Completed | 49 | 40 |
| Not completed | 6 | 5 |
| Withdrew: Lost to follow-up | 4 | 4 |
| Withdrew: Withdrawal by subject | 2 | 1 |
Echocardiographic epicardial fat thickness is an non invasive, inexpensive, reproducible and direct measure of visceral fat. In fact, epicardial fat strongly reflects the intra-abdominal and intra-myocardial fat accumulation as measured by magnetic resonance imaging procedures.
| mm | Liraglutide | Metformin |
|---|---|---|
| Baseline | 9.6 ± 2 | 7.4 ± 1.6 |
| 3-month | 6.8 ± 1.5 | 7.5 ± 1.5 |
| 6-month | 6.2 ± 1.5 | 6.9 ± 1.5 |
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Liraglutide | 0/55 (0%) | 0/55 (0%) | 16/55 (29.1%) |
| Metformin | 0/45 (0%) | 0/45 (0%) | 12/45 (26.7%) |
| Event | Liraglutide | Metformin |
|---|---|---|
| nauseaGastrointestinal disorders | 16/55 | 12/45 |
| Age, Categorical(Participants) | Liraglutide | Metformin | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 45 | 100 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Mean | 50 ± 10 | 52 ± 10 | 50.8 ± 10 |
| Sex: Female, Male(Participants) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Female | 33 | 28 | 61 |
| Male | 22 | 17 | 39 |
| Ethnicity (NIH/OMB)(Participants) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Hispanic or Latino | 21 | 17 | 38 |
| Not Hispanic or Latino | 34 | 28 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Liraglutide | Metformin | Total |
|---|---|---|---|
| United States | 55 | 45 | 100 |
| Epicardial adipose tissue Thickness (EAT)(mm) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Mean | 9.6 ± 2 | 7.4 ± 1.6 | 8.75 ± 1.9 |
| Body Mass Index (BMI)(kg/m2) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Mean | 37.8 ± 7 | 32.6 ± 6 | 35.2 ± 6 |
| HemoglobinA1c (HbA1c)(%) | Liraglutide | Metformin | Total |
|---|---|---|---|
| Mean | 6.6 ± 0.8 | 6.4 ± 0.6 | 6.52 ± 0.6 |
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