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Type 2 Diabetes Mellitus (T2DM)NCT06719661

The Impact of Clinical Pharmacist Intervention and Dapagliflozin as Add-On Therapy in the Management of Type 2 Diabetes Mellitus.

A study testing Dapagliflozin 10mg, Clinical Pharmacist-led Intervention and Standard therapy group in people with Type 2 Diabetes Mellitus (T2DM), run by University of Sulaimani at 2 sites in Iraq.

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

Diabetes mellitus is a progressive endocrine disease characterized by insulin deficiency with or without insulin resistance. Management of type 2 diabetes requires a comprehensive team following and monitoring the disease carefully. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Type 2 Diabetes Mellitus (T2DM)
What is being tested?
Dapagliflozin 10mg, Clinical Pharmacist-led Intervention and Standard therapy group
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
2 sitesIraq
Study dates
1 Dec 2024to 1 Jun 2025
Phase
Interventional
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 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with a diagnosis of type 2 diabetes mellitus having either dual or triple therapy, including (metformin, sulfonylurea, and/or DPP-4 inhibitors).
  • HbA1c level between 7.0% and 10% and patients with HbA1c above 10% but refusing insulin therapy.
  • Willing to provide informed consent.

Who cannot join

  • Presence of comorbidities (e.g., severe renal impairment (eGFR < 30 mL/min/1.73m²), thyroid dysfunction, liver dysfunction).
  • Presence of type 1 diabetes mellitus.
  • History of diabetic ketoacidosis.
  • Pregnancy or breastfeeding.
  • Cognitive impairment or inability to provide informed consent.

Trial locations and contacts

2 sites in 1 country.

Iraq2 sites

  • Endocrine and Diabetes Center

    Sulaymaniyah, Kurdistan Region, 46001

  • Ministry of Higher Education and Scientific research, University of Sulaimani, College of Pharmacy

    Sulaymaniyah, Kurdistan Region, 46001

Other trials in Iraq

About this study

Diabetes mellitus is a progressive endocrine disease characterized by insulin deficiency with or without insulin resistance. Management of type 2 diabetes requires a comprehensive team following and monitoring the disease carefully. Dapagliflozin is a sodium-glucose co-transporter-2 (SGLT2) inhibitor, has been shown to be an effective medication for the treatment of T2DM, and has been demonstrated to improve glycemic control. The investigators believe that enrolling clinical pharmacist intervention as a part of a multidisciplinary approach and dapagliflozin is necessary to provide better patient care in patients that are on dual or triple oral hypoglycemic agents other than dapagliflozin. Therefore, the hypothesis of this study is that the impact and tolerability of clinical pharmacist-led intervention can be comparable to add on dapagliflozin alone on glycemic control in the management of T2DM.

Read the detailed description

The study will be a three-arm prospective, randomized, controlled trial conducted in the Diabetes and endocrine center in Sulaymaniyah, Iraq. Participants will be randomly assigned to one of the following three groups. Group 1 receives dapagliflozin 10 mg as add-on therapy along with their standard dual or triple oral hypoglycemic medicines; group 2 receives clinical pharmacist-led intervention including dosage adjustment, dietary modification, education on the importance of adherence, strategies to improve adherence, and regular follow-up along with their standard dual or triple oral hypoglycemic medicines; group 3 is the standard therapy group when patients are receiving their standard dual or triple therapy only; and the duration of the study is 3 months. Glycemic control will be measured by measurement of HbA1c and fasting plasma glucose level after 3 months. Changes in body weight and BMI will also be done; in addition, compliance will be measured using a hill-bone compliance scale for high blood pressure medication applied to diabetic medication. The expected outcome includes improving both HbA1c and fasting plasma glucose levels in both groups compared to baseline and comparable improvement in parameters between the clinical pharmacist-led intervention group and dapagliflozin 10 mg add-on therapy group.

Being tested
Dapagliflozin 10mg, Clinical Pharmacist-led Intervention, Standard therapy group
Keywords
Uncontrolled type 2 diabetes, Dapagliflozin, Effects on HbA1c, Effects on body weight, Effects on fasting plasma glucose level
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.

  • Dapagliflozin 10mgDrug

    Uncontrolled type 2 diabetic patients receive dapagliflozin 10 mg tablet once daily. They are asked to take it for 3 months, then return for their final assessment after 3 months

  • Clinical Pharmacist-led InterventionOther

    Patients with uncontrolled type 2 diabetes will undergo dosage intensification of their dual or triple oral hypoglycemic medicines up to maximum daily doses. Further, they will be advised on specific dietary modification, education on the importance of adherence, strategies to improve adherence, including giving pill boxes, and regular follow-up every month via telephone-based communication.

  • Standard therapy groupOther

    Patients are receiving their standard dual or triple oral hypoglycemic therapy only.

Study groups in NCT06719661
Study groupRoleWhat they receive
Dapagliflozin as add on therapy groupExperimentalPatients with uncontrolled type 2 diabetes receive dapagliflozin 10 mg once daily for 3 months as add-on therapy to their dual or triple standard therapy without receiving clinical pharmacist-led intervention.
Receives: Drug: Dapagliflozin 10mg
Clinical pharmacist-led intervention groupExperimentalPatients with uncontrolled type 2 diabetes receive clinical pharmacist-led intervention, including dosage adjustment, dietary modification, education on the importance of adherence, strategies to improve adherence, and regular follow-up along with their standard dual or triple oral hypoglycemic medicines
Receives: Other: Clinical Pharmacist-led Intervention
Standard therapy groupOtherPatients with uncontrolled type 2 diabetes receiving their standard dual or triple therapy only
Receives: Other: Standard therapy group

What is being measured

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

  1. HbA1c

    This measures changes in HbA1c from baseline to the end of the study period.

    Measured: 3 months

  2. Fasting Plasma Glucose Level

    This measures changes in fasting plasma glucose level from baseline to the end of the study period.

    Measured: 3 months

  3. Body mass index (BMI)

    This measures changes in weight in kg and height in meters to calculate changes of BMI (kg/m2) from baseline to the end of the study period.

    Measured: 3 months

  4. Waist circumference

    This measures changes in waist circumference in centimeters from baseline to the end of the study period.

    Measured: 3 months

  5. Incidence of adverse events

    This measures the reported incidence of adverse events, including urinary tract and genital infections and hypoglycemia.

    Measured: 3 months

Secondary outcomes (4)

  1. Modified Hill-bone compliance scale

    This measures the difference in adherence of patients to their medicines between baseline and the end of the study period. The questionnaire is composed of 14 item questions: appointment-keeping questions (3-items), diet (2-items), and medication adherence (9-items). The response to each question is one of the following:

    1. All of the Time (Four marks)
    2. Most of the Time (Three marks)
    3. Some of the Time (Two Marks)
    4. None of the Time (One Mark) The interpretation of the scale is done based on the following: Patients with mark scores of 14-28 will be considered as having good or high compliance, and those with mark scores of 29-42 will be considered as having average or medium compliance, while those having mark scores of 43-56 will be considered as having poor or low compliance.

    Measured: 3 months

  2. Lipid Profile

    This measures changes in lipid profile (Total cholesterol, LDL, HDL and Triglyceride) from baseline to the end of the study period

    Measured: 3 months

  3. Blood pressure

    This measures changes in blood pressure from baseline to the end of the study period

    Measured: 3 months

  4. Serum creatinine

    This measures changes in serum creatinine from baseline to the end of the study period

    Measured: 3 months

Timeline

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

  1. First posted6 Dec 2024
  2. Study start1 Dec 2024
  3. Primary completion5 May 2025
  4. Study completion1 Jun 2025

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719661
Sponsor's protocol ID
PH141-24
Status last verified
Jun 2025
First submitted
30 Nov 2024
Last updated
5 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Dapagliflozin 10mg, Clinical Pharmacist-led Intervention and Standard therapy group in people with Type 2 Diabetes Mellitus (T2DM), run by University of Sulaimani at 2 sites in Iraq.

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 3 inclusion and 5 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 5 Jun 2025. 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 Iraq. 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.

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?

HbA1c (time frame: 3 months). The study lists 5 primary outcomes in all. 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 NCT06719661.

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 5 Jun 2025.

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