Trial Outcomes & Findings for Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months. (NCT NCT02670928)
NCT ID: NCT02670928
Last Updated: 2019-04-12
Results Overview
Number (portion) of patients in the active group and control group in whom the body weight decreased by at least 5% compared to Baseline values at 12 months of follow-up
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
130 participants
Primary outcome timeframe
Baseline, Month 12
Results posted on
2019-04-12
Participant Flow
This study was conducted in the following jurisdiction: Russia (2 centers).
Participant milestones
| Measure |
Active Group of Patients
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
30
|
|
Overall Study
COMPLETED
|
90
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
1
|
Reasons for withdrawal
| Measure |
Active Group of Patients
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Miss 3 classes in a row in first 12 wks
|
2
|
0
|
Baseline Characteristics
Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
Baseline characteristics by cohort
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
60.6 Years
STANDARD_DEVIATION 8.9 • n=7 Participants
|
56.0 Years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
99 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Number (portion) of patients in the active group and control group in whom the body weight decreased by at least 5% compared to Baseline values at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
Week 48 (Month 12) - Yes
|
50 Participants
|
4 Participants
|
|
Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
Week 48 (Month 12) - No
|
50 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
|
55 Percentage of Participants
|
40 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 3, Month 6, Month 9, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 12 (Month 3) - Yes
|
40 Percentage of Participants
|
13.3 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 12 (Month 3) - No
|
60 Percentage of Participants
|
86.7 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 24 (Month 6) - Yes
|
34 Percentage of Participants
|
26.7 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 24 (Month 6) - No
|
66 Percentage of Participants
|
73.3 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 36 (Month 9) - Yes
|
39 Percentage of Participants
|
16.7 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 36 (Month 9) - No
|
61 Percentage of Participants
|
83.3 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 48 (Month 12) - Yes
|
50 Percentage of Participants
|
13.3 Percentage of Participants
|
|
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Week 48 (Month 12) - No
|
50 Percentage of Participants
|
86.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Change From Baseline in Cholesterol at Month 12
|
-9.44 Percent change
Standard Error 2.792
|
-8.00 Percent change
Standard Error 3.339
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Change From Baseline in Triglycerides at Month 12
|
-0.479 Percent change
Standard Error 0.1136
|
0.481 Percent change
Standard Error 0.2468
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
Low Density Lipoprotein (LDL)
|
-6.76 Percent change
Standard Error 4.649
|
-11.54 Percent change
Standard Error 4.641
|
|
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
High Density Lipoprotein (HDL)
|
17.46 Percent change
Standard Error 10.967
|
12.68 Percent change
Standard Error 6.089
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Patients were asked 'When did blood sugar level decrease most recently?' and the responses were reported on a Change in Quality of Life (QoL) expressed in percents using the Novartis survey in hypoglycemia and scale of individual perception of PhA (Scale of Borg)
Outcome measures
| Measure |
Active Group of Patients
n=90 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=29 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
During last week
|
5.6 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
From 1 week to 1 month ago
|
1.1 Percentage of participants
|
3.4 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
From 1 to 6 month ago
|
16.7 Percentage of participants
|
17.2 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
More than 6 months ago and within last 12 months
|
11.1 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
More than 12 months ago
|
11.1 Percentage of participants
|
6.9 Percentage of participants
|
|
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
No episode of blood sugar level decrease
|
54.4 Percentage of participants
|
62.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Outcome measures
| Measure |
Active Group of Patients
n=92 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
|
6.640 Percent change
Standard Deviation 1.152
|
7.687 Percent change
Standard Deviation 1.558
|
SECONDARY outcome
Timeframe: Basline, Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
|
1.55 Percent change
Standard Error 7.217
|
-3.03 Percent change
Standard Error 5.079
|
SECONDARY outcome
Timeframe: Month 12Population: Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.
Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up
Outcome measures
| Measure |
Active Group of Patients
n=100 Participants
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 Participants
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
|
32.417 Percent change
Standard Deviation 3.940
|
33.190 Percent change
Standard Deviation 4.075
|
Adverse Events
Active Group of Patients
Serious events: 6 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group of Patients
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Active Group of Patients
n=100 participants at risk
Active group of patients underwent program of active lifestyle management (healthy nutrition, physical exercises, psychological counselling and classes on diabetes) in first 12 weeks of the study.
|
Control Group of Patients
n=30 participants at risk
Control group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
|
|---|---|---|
|
Cardiac disorders
Acute Myiocardial Infarction
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Cardiac disorders
Myocardial Ischemia
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Gastrointestinal disorders
Duodenal ulcer Haemorrhage
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Gastrointestinal disorders
Gastrointestinal Inflammation
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic Neoplasm
|
100.0%
1/1 • Number of events 1 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
—
0/0 • Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). Each patient was assessed for up to 12 months.
The Safety Set consisted of all patients in the active group who started participating in the lifestyle correction program and all patients in the control group for whom the observation was started
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER