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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.
Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group of patients | Active Comparator | 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. |
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| Control group of patients | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifestyle intervention | Behavioral | Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 | 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 | Baseline, Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12 | Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline | Baseline, Month 12 |
| Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Kazan' | 420012 | Russia | |||
| Novartis Investigative Site |
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This study was conducted in the following jurisdiction: Russia (2 centers).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Control Group of Patients |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2015 | Apr 5, 2018 |
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Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up |
| Baseline, Month 3, Month 6, Month 9, Month 12 |
| Percentage Change From Baseline in Cholesterol at Month 12 | Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up | Baseline, Month 12 |
| Percentage Change From Baseline in Triglycerides at Month 12 | Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up | Baseline, Month 12 |
| Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12 | Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up | Baseline, Month 12 |
| Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12 | 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) | Baseline, Month 12 |
| Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12 | Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up | Baseline, Month 12 |
| Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 | Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up | Basline, Month 12 |
| Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12 | Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up | Month 12 |
| Moscow |
| 117036 |
| Russia |
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. |
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All patients in the active and control groups were included in the population of all enrolled patients, the safety population and the full analysis set (FAS).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 | 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 | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Number | Participants | Baseline, Month 12 |
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| Secondary | Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12 | Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Baseline, Month 12 |
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| Secondary | Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline | Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Number | Percentage of Participants | Baseline, Month 3, Month 6, Month 9, Month 12 |
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| Secondary | Percentage Change From Baseline in Cholesterol at Month 12 | Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Error | Percent change | Baseline, Month 12 |
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| Secondary | Percentage Change From Baseline in Triglycerides at Month 12 | Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Error | Percent change | Baseline, Month 12 |
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| Secondary | Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12 | Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Error | Percent change | Baseline, Month 12 |
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| Secondary | Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12 | 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) | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Number | Percentage of participants | Baseline, Month 12 |
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| Secondary | Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12 | Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Deviation | Percent change | Baseline, Month 12 |
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| Secondary | Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 | Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Error | Percent change | Basline, Month 12 |
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| Secondary | Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12 | Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up | Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done. | Posted | Mean | Standard Deviation | Percent change | Month 12 |
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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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 100 | 6 | 100 | 0 | 100 |
| EG001 | 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. | 1 | 30 | 2 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Myiocardial Infarction | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Myocardial Ischemia | Cardiac disorders | MedDRA (19.0) | Systematic Assessment |
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| Duodenal ulcer Haemorrhage | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Gastrointestinal Inflammation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Humerus Fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | Systematic Assessment |
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| Oesophageal Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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| Pancreatic Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (19.0) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 4, 2017 | Apr 5, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Oriental |
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