Phase 4
N=130
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Type 2 Diabetes Mellitus (T2DM)
Bottom Line
View on ClinicalTrials.gov: NCT02670928 ↗Enrolled (actual)
130
Serious AEs
6.2%
Results posted
Apr 2019
Primary outcome: Primary: Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 — 50; 4; 50; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lifestyle intervention (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Apr 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 |
50; 4; 50; 26 | — |
| SECONDARY Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12 |
55; 40 | — |
| SECONDARY Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline |
40; 13.3; 60; 86.7; 34; 26.7 | — |
| SECONDARY Percentage Change From Baseline in Cholesterol at Month 12 |
-9.44; -8.00 | — |
| SECONDARY Percentage Change From Baseline in Triglycerides at Month 12 |
-0.479; 0.481 | — |
| SECONDARY Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12 |
-6.76; -11.54; 17.46; 12.68 | — |
| SECONDARY Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12 |
5.6; 3.4; 1.1; 3.4; 16.7; 17.2 | — |
| SECONDARY Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12 |
6.640; 7.687 | — |
| SECONDARY Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 |
1.55; -3.03 | — |
| SECONDARY Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12 |
32.417; 33.190 | — |
Summary
This study was aimed to achieve of long-term weight loss in T2DM patients by use of comprehensive lifestyle changes program, providing patients with structured diet, exercise plan, group behavioral support and group education. Additionally the study was designed to establish reduction of the body weight leads to the improvement of glycemic and lipid metabolism, and also reducing blood pressure level. The study was also directed to show that lifestyle changes program in T2DM patients can lead to decreasing of hospitalization rate and healthcare consumption. In order to demonstrate a change from standard of care, data were to be collected from a parallel cohort from the same centers.
Eligibility Criteria
Inclusion Criteria
- Signed Informed Consent. Written informed consent must be obtained before any assessment is performed.
•≥ 18 years
- Type 2 diabetes
- The Body Mass Index is from 28 to 40 kg/m^2
Exclusion Criteria
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- Type 1 diabetes
- Proliferative retinopathy
- Renal impairment: serum creatinine >1.5 mg/dL, creatinine clearance < 40 ml/min and/or proteinuria
- The lack of ability to perform the physical exercises due to the orthopedic or cardiovascular disorders
- Chronic alcoholism, acute alcoholic intoxication
Data sourced from ClinicalTrials.gov (NCT02670928). 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.