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Type 2 DiabetesPhase 4NCT01919489

Liraglutide Hospital Discharge Trial

A Phase 4 study testing Liraglutide + OADs and Glargine + OADs in people with Type 2 Diabetes, run by Emory University at 5 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

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Liraglutide + OADs and Glargine + OADs
Could I receive a placebo?
No, everyone receives an active treatment
How many people
273 participants
Where
5 sitesUnited States
Study dates
Mar 2014to 30 Aug 2020
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males or females between the ages of 18 and 80 years discharged after hospital admission from non- ICU general surgery and medicine services (excluding gastrointestinal and cardiac surgeries).
  • Admission HbA1c between 7% and 10%
  • Patients with T2D treated with diet alone or with oral antidiabetic agents as monotherapy or in combination therapy (excluding GLP1 receptor agonists) or on low-dose insulin therapy (TDD ≤0.4 unit/kg/day) prior to admission.
  • Subjects with a hospital admission BG < 400 mg/dL without laboratory evidence of diabetic ketoacidosis (serum bicarbonate < 18 mEq/L or positive serum or urinary ketones).
  • BMI > 25 Kg/m2 and ≤ 45 Kg/m2

Who cannot join

  • Age < 18 or > 80 years.
  • Subjects with stress hyperglycemia (BG > 140 mg/dL and HbA1c < 6.5%)
  • Subjects with a history of type 1 diabetes
  • Treatment with insulin or GLP-1 analogs during the past 3 months prior to admission.
  • Recurrent severe hypoglycemia or hypoglycemic unawareness.
  • Subjects with gastrointestinal obstruction, gastroparesis, or those expected to require gastrointestinal suction.
Show all 13Show fewer
  • History of medullary thyroid cancer or multiple endocrine neoplasias
  • Patients with acute or chronic pancreatitis, pancreatic cancer, or gallbladder disease.
  • Patients with clinically significant hepatic disease (cirrhosis, jaundice, end-stage liver disease, portal hypertension) and elevated ALT and AST > 3 times upper limit of normal, or significantly impaired renal function (GFR < 30 ml/min).
  • Treatment with oral or injectable corticosteroid (equivalent or higher than prednisone 5mg/day), parenteral nutrition, and immunosuppressive treatment.
  • Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
  • Female subjects who are pregnant or breastfeeding at the time of enrollment into the study.
  • Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice).

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory University Hospital

    Atlanta, Georgia, 30324

  • Emory Universtiy Hospital at MIdtown

    Atlanta, Georgia

  • University of Miami

    Miami, Florida

  • State University of NY at Buffalo

    New York, New York

Other trials in United States

About this study

Official title: A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Increasing evidence indicates that incretin-based agents are safe and effective for the hospital management of patients with type 2 diabetes (T2D).

Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food intake and body weight and improve ß-cell function when administered subcutaneously. Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy. When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective studies; however, have compared the efficacy and safety of liraglutide in the hospital setting or after hospital discharge.

The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in medicine patients with T2D after hospital discharge.

Read the detailed description

Specific Aim: To determine whether treatment with liraglutide (Victoza®) will result in similar glycemic control (HbA1c at 26 weeks) and a lower rate of hypoglycemic events compared to treatment with glargine (Lantus®) in patients with T2D after hospital discharge. Patients with poorly controlled (HbA1c >7%-10%) T2D treated with diet or oral antidiabetic agents or low dose insulin naïve (0.4u/kg/day) prior to admission will be randomized to liraglutide or glargine in combination to OADs at hospital discharge.

Conditions
Type 2 Diabetes
Being tested
Liraglutide + OADs, Glargine + OADs
Keywords
Incretins, Liraglutide, Glargine, Randomized controlled trial, basal insulin, hospital discharge, inpatient diabetes
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Liraglutide + OADsDrug

    Also called Victoza® + OADs

    Liraglutide subcutaneously daily

  • Glargine + OADsDrug

    Also called Glargine (Lantus®) + OADs

    Glargine once daily subcutaneously

Study groups in NCT01919489
Study groupRoleWhat they receive
Liraglutide + OADsExperimentalLiraglutide once daily in combination to oral anti-diabetic agents (OADs)
Receives: Drug: Liraglutide + OADs
Glargine + OADsActive comparatorGlargine once daily in combination to oral anti-diabetic agents (OADs)
Receives: Drug: Glargine + OADs

What is being measured

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

  1. Glycemic Control at Hospital Discharge and 6 Months Follow up

    To determine differences in HbA1c concentration at 26 weeks from discharge between liraglutide and glargine insulin therapy

    Measured: Hospital discharge, 6 months (26 weeks)

Secondary outcomes (14)

  1. Fasting and Postprandial Blood Glucose (BG) Concentration After Follow up of 26 Weeks

    To determine differences in BG concentration between liraglutide and glargine insulin therapy

    Measured: After discharge, average at 3 months (12 week) and 6 months (26 weeks)

  2. Hypoglycemic Episodes

    Number of participants who had at least one hypoglycemic event (<70 mg/dl) and severe hypoglycemic event (<40 mg/dl)

    Measured: After discharge, average 6 months

  3. HbA1c <7.0% and no Hypoglycemia

    Percent of patients with 26 week HbA1c <7.0% and no hypoglycemia

    Measured: After discharge, average 6 months

  4. HbA1c <7.0% and no Weight Gain

    Percent of patients with 26 week HbA1c <7.0% and no weight gain

    Measured: After discharge, average 6 months

  5. HbA1c <7.0% and no Hypoglycemia

    Percent of patients with 12 week HbA1c <7.0% and no hypoglycemia

    Measured: After discharge, average 12 weeks

  6. Change in Body Weight From Baseline

    Change in body weight from baseline after 6 months of follow up (26 weeks)

    Measured: After discharge, average 6 months

  7. Change in BMI

    Change in BMI after 6 months from baseline

    Measured: Baseline, and follow up after discharge (average 6 months)

  8. Total Daily Dose of Insulin

    Evaluate the total daily dose of insulin needed in the group receiving glargine

    Measured: After discharge, average 6 months

  9. Change in Cardiovascular Risk Factors: Blood Pressure

    Cardiovascular risk factors including changes in systolic and diastolic blood pressure from baseline to 26 weeks post-intervention

    Measured: Baseline, 26 weeks post-intervention

  10. Cardiovascular Risk Factor: Heart Rate

    Cardiovascular risk: heart rate at baseline and 26 weeks post-intervention

    Measured: 26 weeks post-intervention

  11. Cardiovascular Risk Factor: Lipid Profile

    Lipid profile was measured with total cholesterol level results at 26 weeks post-intervention. This outcome was not part of standard of care.

    Measured: 26 weeks post-intervention

  12. Emergency Room Visits and Readmissions

    Number of participants who had at least one emergency room visit and hospital readmissions

    Measured: After discharge, average 6 months

  13. Acute Renal Failure

    Acute renal failure during the 26-week follow-up defined as a clinical diagnosis of acute renal failure with documented new-onset abnormal renal function (increment in creatinine > 0.5 mg/dL from baseline)

    Measured: After discharge, average 6 months

  14. Self-measured Blood Glucose (SMBG) 7-point Profiles at 26 Weeks Follow up

    Number of participants that reported self-measured blood glucose (SMBG) 7-point profiles at 26 weeks follow up

    Measured: 26 weeks post-intervention

Timeline

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

  1. First posted9 Aug 2013 (estimated)
  2. Study startMar 2014
  3. Primary completion30 Aug 2020
  4. Study completion30 Aug 2020

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
273 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01919489
Sponsor's protocol ID
IRB00068128
Other IDs
(UTN) U1111-1139-2991
Status last verified
Aug 2021
First submitted
30 Jul 2013
Last updated
3 Nov 2021
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liraglutide + OADs and Glargine + OADs in people with Type 2 Diabetes, run by Emory University at 5 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 5 inclusion and 13 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 3 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Glycemic Control at Hospital Discharge and 6 Months Follow up (time frame: Hospital discharge, 6 months (26 weeks)). 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 NCT01919489.

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 3 Nov 2021.

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