Type 2 Diabetes Mellitus (T2DM)Phase 4NCT02670928

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

A Phase 4 study testing Lifestyle intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Type 2 Diabetes Mellitus (T2DM)
What is being tested?: Lifestyle intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 130 participants
Where: 2 sitesRussia
Study dates: 20 Jul 2015to 6 Apr 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

Novartis Investigative Site
Kazan', 420012
Novartis Investigative Site
Moscow, 117036

Other trials in Russia

About this study

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.

Read the 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.

Conditions: Type 2 Diabetes Mellitus (T2DM)
Being tested: Lifestyle intervention
Keywords: Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG
Medical subject headings: Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lifestyle interventionBehavioural
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 groups in NCT02670928
Study group	Role	What they receive
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. Receives: Behavioral: Lifestyle intervention
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. Receives: Behavioral: Lifestyle intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline, Month 12

Secondary outcomes (9)

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
Measured: Baseline, Month 12
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jul 20156 Apr 2017

First posted2 Feb 2016 (estimated)
Study start20 Jul 2015
Primary completion6 Apr 2017
Study completion6 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 130 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02670928
Sponsor's protocol ID: CLAF237ARU05
Status last verified: Apr 2019
First submitted: 13 Jan 2016
Last updated: 12 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Truway Diagnostic Tools in Primary Care
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All Type 2 Diabetes Mellitus (T2DM) trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interventional Study of Active Weight Management in Patients With Type 2 Diabetes and Obesity in Routine Clinical Practice During 12 Months.
ClinicalTrials.gov ID: NCT02670928
Acronym / sponsor ID: CLAF237ARU05
Conditions: Type 2 Diabetes Mellitus (T2DM)
Keywords: Diabetes, lifestyle change, weight management, control of glycemic in HbA1C and FPG
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 130 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 20 Jul 2015 (actual)
Primary completion: 6 Apr 2017 (actual)
Study completion: 6 Apr 2017 (actual)
First posted: 2 Feb 2016 (estimated)
Results: Posted 12 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Active group of patients	Active comparator	Behavioral: Lifestyle interventionActive 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	Experimental	Behavioral: Lifestyle interventionControl group pf patients were being monitored for the same criteria as active group but did not take part in the lifestyle change management program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lifestyle interventionPatients 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.	Behavioural	Active group of patients, Control group of patients

Primary outcome

Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12
Time frame: 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

9 secondary outcomes

Percentage of Patients Who Achieved a Decrease in Blood Pressure Values From Baseline at Month 12
Time frame: Baseline, Month 12
Percentage of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline
Time frame: Baseline, Month 3, Month 6, Month 9, Month 12
Percentage Change From Baseline in Cholesterol at Month 12
Time frame: Baseline, Month 12
Percentage Change From Baseline in Triglycerides at Month 12
Time frame: Baseline, Month 12
Percentage Change From Baseline in Lipid Protein of High and Low Density at Month 12
Time frame: Baseline, Month 12
Percentage of Participants With Change From Baseline in Quality of Life (QoL) at Month 12
Time frame: Baseline, Month 12
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Month 12
Time frame: Baseline, Month 12
Percentage Change From Baseline in Fasting Plasma Glucose (FPG) at Month 12
Time frame: Basline, Month 12
Percentage Hange From Baseline in Body Mass Index (BMI) at Month 12
Time frame: Month 12

Results and safety

Results posted to the registry on 12 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Group of Patients	100	90
Control Group of Patients	30	29

Primary outcome: Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12

Time frame: Baseline, Month 12. Number. Unit: Participants

Measure	Active Group of Patients n = 100	Control Group of Patients n = 30
Week 48 (Month 12) - Yes	50	4
Week 48 (Month 12) - No	50	26

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

9 secondary outcomes are reported in the full results.

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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Group of Patients	6 of 100 (6%)	0 of 100 (0%)	0 of 100
Control Group of Patients	2 of 30 (6.7%)	0 of 30 (0%)	1 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Type 2 Diabetes Mellitus (T2DM)

Active, not recruiting
Groceries Plus Multi-Component Lifestyle Intervention for Adults With Hypertension and Type 2 Diabetes
Hypertension, Type 2 Diabetes Mellitus (T2DM)
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes
T2DM (Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Study to Evaluate the Effects of Enicepatide in Participants With Obesity or Overweight, With or Without Type 2 Diabetes
Obesity, Overweight
Recruiting
Lifestyle Medicine for Type 2 Diabetes Remission in Pakistan
Type-2 Diabetes Mellitus (T2DM), Diabetes Remission

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis Pharmaceuticals study director

Novartis Pharmaceuticals

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lifestyle intervention in people with Type 2 Diabetes Mellitus (T2DM), run by Novartis Pharmaceuticals at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients With Clinically Significant Weight Reduction (>5%) Compared to Baseline at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02670928.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.