Phase 4
Completed N=71
Adding Liraglutide to High Dose Insulin: Breaking the Cycle
Source: ClinicalTrials.gov NCT01505673 ↗Enrolled (actual)
71
Serious AEs
9.9%
Results posted
Dec 2017
Primary outcomePrimary: Glycemic Control Measured by HbA1c — 7.9; 8.9 Percent HbA1c
◆ Published Evidence
Established
73citations · ~7 / year
Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin.
Summary
The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (>1.8 units/kg/day) in patients with uncontrolled (HbA1c >7.5%) type 2 diabetes mellitus will improve blood sugar control.
It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and assesses blood pressure, lipid profile, and liver function. Finally it will look at patient quality of life and safety.
Linked Publications (2)
-
Mechanisms of Action of Liraglutide in Patients With Type 2 Diabetes Treated With High-Dose Insulin.
-
Effect of Adding Liraglutide vs Placebo to a High-Dose lnsulin Regimen in Patients With Type 2 Diabetes: A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycemic Control Measured by HbA1c |
7.9; 8.9 | — |
| SECONDARY Pancreatic and Hepatic Triglyceride Content |
12.3; 12.2; 12.53; 14.64 | — |
| SECONDARY Weight |
114; 117 | — |
| SECONDARY Beta-Cell Function |
1234.6; 922.9 | — |
| SECONDARY Glucagon |
107.3; 93.8 | — |
| SECONDARY Total Daily Insulin Dose |
200; 218 | — |
| SECONDARY Number of Daily Injections |
3.7; 3.8 | — |
| SECONDARY Blood Pressure |
134; 135; 80.5; 74.3 | — |
| SECONDARY Lipid Profile |
154; 152; 83.9; 76.3; 36.6; 37.6 | — |
| SECONDARY Liver Function Blood Test |
25.8; 36.0; 26.4; 32.1 | — |
| SECONDARY Hypoglycemic Events |
1.1; 0.7 | — |
| SECONDARY Quality of Life Survey (QoL) - General Health Perception |
3.1; 3.6 | — |
| SECONDARY Beta-Cell Function |
1234.6; 922.9 | — |
| SECONDARY Matsuda Index as a Measure of Beta Cell Function |
2.88; 3.12 | — |
| SECONDARY Beta-cell Function |
1234.6; 922.9 | — |
| SECONDARY Ratio (AUC C-peptide/AUC Glucose) |
0.019; 0.013 | — |
| SECONDARY AUC Glucose |
71747; 79278 | — |
| SECONDARY Quality of Life Survey (QoL) - Current Health Perception |
2.1; 2.6 | — |
| SECONDARY Quality of Life Survey (QoL) - Treatment Satisfaction |
2.4; 2.7 | — |
| SECONDARY Quality of Life Survey (QoL) - Treatment Impact |
2.3; 2.6 | — |
| SECONDARY Quality of Life Survey (QoL) - Social or Vocational Worry |
1.5; 1.0 | — |
| SECONDARY Quality of Life Survey (QoL) - Hypoglycemia Fear |
1.9; 2.0 | — |
| SECONDARY Quality of Life Survey (QoL) - Glycemia Control Perception |
2.0; 2.9 | — |
| SECONDARY Quality of Life Survey (QoL) - Lifestyle Flexibility |
2.2; 2.6 | — |
| SECONDARY Quality of Life Survey (QoL) - Social Stigma |
2.5; 2.4 | — |
| SECONDARY Quality of Life Survey (QoL) - Satisfaction With Insulin Treatment |
1.6; 2.3 | — |
| SECONDARY Quality of Life Survey (QoL) - Willingness to Continue Insulin Treatment |
1.0; 2.1 | — |
Eligibility Criteria
Inclusion Criteria
- Type 2 diabetes mellitus
- Insulin dose of >1.8 units/kg/day (represents total daily insulin dose, regardless of formulation, regimen, number of daily shots)
- HbA1c ≥ 7.5% and ≤ 11%
- Age ≥ 18
- Stable comorbidities on stable treatment regimens
- Stable dose of all oral hypoglycemics for ≥ 3 months prior to enrollment
- Ability to provide informed consent before any trial-related activities
Exclusion Criteria
- Type 1 diabetes mellitus
- Any contraindication to the MRI procedure (metallic implants, severe claustrophobia, pregnancy, unable to lie still on a hard table for the duration of the procedure, weight above 400 lb - limit of the MRI table, magnet's inner circumference smaller than the largest body circumference)
- History of any pancreatic disease as it might interfere with the pancreatic TG measurement (i.e. pancreatitis, tumors, cysts, type 1 diabetes, any pancreatic surgery)
- End Stage Renal Disease on dialysis due to increased risk of hypoglycemia, and possible interference with accurate measurement of HbA1c
- Incretin therapy (any GLP-1 agonist or DPP-IV inhibitor)
- Unstable or decompensated comorbidities
- Personal or family history of medullary thyroid carcinoma or MEN-2 syndrome
- Severe gastroparesis
- Pregnancy, breast feeding, intention to become pregnant, or not using adequate contraceptive measures
- Organ transplant recipient or waiting list candidate
- Steroid use (current or potential use during the trial)
- Known/suspected allergy to trial medication, excipients, or related products
- Contraindications to study medications, worded specifically as stated in the product's prescribing information
- Non-English speaking volunteers since no interpreters are available and the safety of the volunteers could be jeopardized if adequate and reliable communication is not possible.
Data sourced from ClinicalTrials.gov (NCT01505673) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.