Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.

• Sponsor: Novartis Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02670928
• Collaborator: (none)
• Enrollment: 130
• Locations: 2
• Arms: 2
• Actual Duration (Months): 20.6
• Patients Per Site: 65
• Patients Per Site Per Month: 3.2

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus (T2DM)	Behavioral: Lifestyle intervention	Phase 4

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
• Actual Study Start Date: Jul 20, 2015
• Actual Primary Completion Date: Apr 6, 2017
• Actual Study Completion Date: Apr 6, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Behavioral: Lifestyle intervention; 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.
Experimental: 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.	Behavioral: Lifestyle intervention; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 [Baseline, 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

Secondary Outcome Measures

1. Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12 [Baseline, 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

2. Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline [Baseline, Month 3, Month 6, Month 9, Month 12]

   Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up

3. Percentage Change From Baseline in Cholesterol at Month 12 [Baseline, Month 12]

   Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up

4. Percentage Change From Baseline in Triglycerides at Month 12 [Baseline, Month 12]

   Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up

5. Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12 [Baseline, Month 12]

   Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up

6. Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12 [Baseline, 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)

7. Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12 [Baseline, Month 12]

   Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up

8. Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12 [Basline, Month 12]

   Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up

9. Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12 [Month 12]

   Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Kazan		Russian Federation	420012
2	Novartis Investigative Site	Moscow		Russian Federation	117036

Sponsors and Collaborators

• Novartis Pharmaceuticals

Investigators

• Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study Documents (Full-Text)

• Study Protocol - Jul 29, 2015
• Statistical Analysis Plan - Jul 4, 2017

More Information

Publications

None provided.

• Responsible Party: Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02670928
• Other Study ID Numbers: CLAF237ARU05
• First Posted: Feb 2, 2016
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Novartis Pharmaceuticals: Diabetes; lifestyle change; weight management; control of glycemic in HbA1C and FPG
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Recruitment Details	This study was conducted in the following jurisdiction: Russia (2 centers).

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Period Title: Overall Study
STARTED	100	30
COMPLETED	90	29
NOT COMPLETED	10	1

Baseline Characteristics

Arm/Group Title	Active Group of Patients	Control Group of Patients	Total
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.	Total of all reporting groups
Overall Participants	100	30	130
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.6 (10.2)	60.6 (8.9)	56.0 (10.2)
Sex: Female, Male (Count of Participants)
Female	69 69%	19 63.3%	88 67.7%
Male	31 31%	11 36.7%	42 32.3%
Race/Ethnicity, Customized (Number) [Number]
Caucasian	99 99%	29 96.7%	128 98.5%
Oriental	1 1%	1 3.3%	2 1.5%

Outcome Measures

1. Primary Outcome

Title	Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
Description	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
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Week 48 (Month 12) - Yes	50 50%	4 13.3%
Week 48 (Month 12) - No	50 50%	26 86.7%

2. Secondary Outcome

Title	Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
Description	Decrease in blood pressure value was defined as at least 5 millimeters mercury (mmHg) in systolic and diastolic values in comparison to Baseline
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Number [Percentage of Participants]	55 55%	40 133.3%

3. Secondary Outcome

Title	Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Description	Number (portion) of patients achieved weight loss by at least 5% in comparison with Baseline at 3, 6, 9 months of follow-up
Time Frame	Baseline, Month 3, Month 6, Month 9, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Week 12 (Month 3) - Yes	40 40%	13.3 44.3%
Week 12 (Month 3) - No	60 60%	86.7 289%
Week 24 (Month 6) - Yes	34 34%	26.7 89%
Week 24 (Month 6) - No	66 66%	73.3 244.3%
Week 36 (Month 9) - Yes	39 39%	16.7 55.7%
Week 36 (Month 9) - No	61 61%	83.3 277.7%
Week 48 (Month 12) - Yes	50 50%	13.3 44.3%
Week 48 (Month 12) - No	50 50%	86.7 289%

4. Secondary Outcome

Title	Percentage Change From Baseline in Cholesterol at Month 12
Description	Analysis of percentage changes in lipid profile (cholesterol, mmol/l) compared to Baseline at 12 months of follow-up
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Mean (Standard Error) [Percent change]	-9.44 (2.792)	-8.00 (3.339)

5. Secondary Outcome

Title	Percentage Change From Baseline in Triglycerides at Month 12
Description	Analysis of percentage in lipid profile (triglycerides, mmol/l) compared to Baseline at 12 months of follow-up
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Mean (Standard Error) [Percent change]	-0.479 (0.1136)	0.481 (0.2468)

6. Secondary Outcome

Title	Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
Description	Analysis of percentage in lipid profile (LDL, mmol/l and HDL, mmol/l) compared to Baseline at 12 months of follow-up
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Low Density Lipoprotein (LDL)	-6.76 (4.649)	-11.54 (4.641)
High Density Lipoprotein (HDL)	17.46 (10.967)	12.68 (6.089)

7. Secondary Outcome

Title	Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
Description	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)
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	90	29
During last week	5.6 5.6%	3.4 11.3%
From 1 week to 1 month ago	1.1 1.1%	3.4 11.3%
From 1 to 6 month ago	16.7 16.7%	17.2 57.3%
More than 6 months ago and within last 12 months	11.1 11.1%	6.9 23%
More than 12 months ago	11.1 11.1%	6.9 23%
No episode of blood sugar level decrease	54.4 54.4%	62.1 207%

8. Secondary Outcome

Title	Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
Description	Analysis of percentage changes in Glycosylated hemoglobin (HbA1c, %) levels compared to Baseline at 12 months follow-up
Time Frame	Baseline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	92	30
Mean (Standard Deviation) [Percent change]	6.640 (1.152)	7.687 (1.558)

9. Secondary Outcome

Title	Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Description	Analysis of percentage changes in Fasting Plasma Glucose (FPG, mmol/l) levels compared to Baseline at 12 months of follow-up
Time Frame	Basline, Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Mean (Standard Error) [Percent change]	1.55 (7.217)	-3.03 (5.079)

10. Secondary Outcome

Title	Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
Description	Changes of Baseline in Body Mass Index (BMI) levels expressed in percents compared to Baseline at 12 months of follow-up
Time Frame	Month 12

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) using the Last Observation Carried Forward (LOCF) approach for imputing missing data. Only descriptive analysis done.

Arm/Group Title	Active Group of Patients	Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
Measure Participants	100	30
Mean (Standard Deviation) [Percent change]	32.417 (3.940)	33.190 (4.075)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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
Arm/Group Title	Active Group of Patients		Control Group of Patients
Arm/Group Description	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 pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.
All Cause Mortality
	Active Group of Patients		Control Group of Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		1/30 (3.3%)
Serious Adverse Events
	Active Group of Patients		Control Group of Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/100 (6%)		2/30 (6.7%)
Cardiac disorders
Acute Myiocardial Infarction	1/1 (100%)	1	1/1 (100%)	1
Myocardial Ischemia	1/1 (100%)	1	0/0 (NaN)	0
Gastrointestinal disorders
Duodenal ulcer Haemorrhage	1/1 (100%)	1	0/0 (NaN)	0
Gastrointestinal Inflammation	0/0 (NaN)	0	1/1 (100%)	1
Injury, poisoning and procedural complications
Humerus Fracture	1/1 (100%)	1	0/0 (NaN)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal Carcinoma	1/1 (100%)	1	0/0 (NaN)	0
Pancreatic Neoplasm	1/1 (100%)	1	0/0 (NaN)	0
Other (Not Including Serious) Adverse Events
	Active Group of Patients		Control Group of Patients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/100 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.