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Quality of LifePhase 4DQOLNCT05167513

Monitoring Parameters Beyond Glycemic Control: Impact of Sitagliptin on Quality of Life in Type 2 Diabetes Patients

A Phase 4 study testing Metformin / Sitagliptin Oral Tablet in people with Quality of Life and Type 2 Diabetes, run by Getz Pharma at 1 site in Pakistan.

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

Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Metformin / Sitagliptin Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
1 sitePakistan
Study dates
1 Jan 2021to 28 Apr 2022
Phase
Phase 4
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patient with Type 2 Diabetes mellitus between 18 to 65 years
  • HbA1C 7% - 10%
  • who can give informed consent.
  • Patient uncontrolled on metformin and lifestyle modification from at least 3 months or who are metformin resistant

Who cannot join

  • type 1 diabetes
  • ≥1 episode of Diabetic Ketoacidosis and/or hyperosmolar hyperglycemic state,
  • ≥1 episode of severe hypoglycaemia,
  • Pregnant or lactating women,
  • Pancreatitis,
  • any serious complications or hypersensitivity

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

  • Primary Care Diabetes Association

    Karachi, Sindh, 75330

Other trials in Pakistan

About this study

Scarcity of local patients' quality of life data assessing diabetes treatment led us design a protocol to assess improvement in the quality of life of patients with Type II Diabetes mellitus. Quality of life measures are designed to enable patients' perspectives on the impact of health \& healthcare interventions on their lives to be assessed \& taken into account in clinical decision making \& research. Its an open label experimental study where participants are assessed for quality of life impact over 6 months duration on Metformin + Sitagliptin therapy. Their safety and efficacy profiles will also be monitored

Read the detailed description

Study Objective: To assess the changes in quality of life (QOL) in patients with type 2 diabetes mellitus receiving sitagliptin plus metformin therapy in routine care.

Study design: Open label, prospective, multicenter, experimental study.

Sample size: The sample size is 157. To overcome loss to follow-ups, total n=300 will be recruited where each site will enroll 30 patients.

Number of Site: There will be 10 sites.

Duration of study: 12 months (data lock point will be the completion of 6 months of follow-up from the time of last patient's enrollment date)

Study Treatment: Dose of Sitagliptin + Metformin (Treviamet® pharmaceutical brand used locally) :

For Sitagliptin + metformin: [50mg+500mg, 50mg+850mg, 50mg+1000mg] For Sitagliptin + metformin Extended Release (XR): [50mg+500mg, 50mg+1000mg].

Safety Assessment: Patient will be monitored for Hypoglycemia, Nausea, Vomiting, Diarrhea, Abdominal Discomfort, Flatulence, Asthenia, Indigestion Other adverse events and serious adverse events.

Follow up visits: After recruitment, patient is supposed to have three visits for follow-ups.

Visit 1: 4 to 6 weeks of initiation of therapy. Visit 02: At 12 weeks of initiation of therapy. Visit 03: At 24 weeks of initiation of therapy.

Study outcomes:

Primary (QoL outcomes): Diabetes Quality of Life assessment using DQOL-13 questionnaire.

Secondary (Safety and Efficacy outcomes): Frequency of adverse events and serious adverse events during the course of study follow-up. Change from baseline in HbA1c % and FBS (mg/dl) to the last-observation on treatment.

Ethical consideration: The ethical approval of study is taken from Pakistan Medical Association. The study will be conducted in compliance with the protocol, good clinical practices (GCP), the ethical principles that have their origin in the Declaration of Helsinki and the applicable regulatory requirements.

Being tested
Metformin / Sitagliptin Oral Tablet
Keywords
Quality of life, Type 2 Diabetes mellitus, Sitagliptin, Metformin
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • Metformin / Sitagliptin Oral TabletDrug

    Metformin and sitagliptin are oral diabetes medicines that help control blood sugar levels.

    Metformin works by decreasing glucose (sugar) production in the liver and decreasing absorption of glucose by the intestines. Sitagliptin works by regulating the levels of insulin your body produces after eating.

    Metformin and sitagliptin is a combination medicine that is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. metformin and sitagliptin is not for treating type 1 diabetes.

Study groups in NCT05167513
Study groupRoleWhat they receive
Uncontrolled Diabetes with Metformin or Metformin resistantExperimentalNot described
Receives: Drug: Metformin / Sitagliptin Oral Tablet

What is being measured

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

  1. Diabetes Quality of Life assessment using DQOL-13 questionnaire

    Satisfaction (6 questions) Impact (4 questions) Worry (3 questions)

    Scoring from 1 to 5 for worst to best quality at each question (low score means poor quality)

    Assessment at enrollment and follow ups (at 1st, 3rd and 6th months)

    Measured: 6 months

Secondary outcomes (2)

  1. Frequency of adverse events and serious adverse events during the course of study follow-up

    Measured: 6 months

  2. Change from baseline in HbA1c % and fasting blood sugar FBS (mg/dl) to the last-observation on treatment

    Measured: 6 months

Timeline

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

  1. First posted22 Dec 2021
  2. Study start1 Jan 2021
  3. Primary completion28 Apr 2022
  4. Study completion28 Apr 2022

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05167513
Sponsor's protocol ID
GTZ-DM-002-20
Acronym
DQOL
Status last verified
Apr 2022
First submitted
29 Nov 2021
Last updated
4 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Diabetes Quality of Life (DQOL) scores, HbA1c, Fasting Blood Sugars (FBS) (masking patients' identity)

Publications

  • Khan A, Kanpurwala MA, Khan RA, Mahmudi NF, Lohano V, Ahmed S, Khan M, Uddin F, Ali SM, Saghir M, Baqar Abidi SH, Kamal J. Impact of Treviamet(R) & Treviamet XR(R) on quality of life besides glycemic control in type 2 DM patients. BMC Endocr Disord. 2023 Nov 8;23(1):244. doi: 10.1186/s12902-023-01492-2.

    PubMed 37940936

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Metformin / Sitagliptin Oral Tablet in people with Quality of Life and Type 2 Diabetes, run by Getz Pharma at 1 site in Pakistan.

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 4 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Diabetes Quality of Life assessment using DQOL-13 questionnaire (time frame: 6 months). 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 NCT05167513, which also lists 1 linked publication.

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 4 May 2022.

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