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Type 2 Diabetes MellitusPhase 3NCT03608358

Safety and Efficacy of Dapagliflozin in Asian T2DM Subjects With Inadequate Glycemic Control on Metformin/Saxagliptin

A Phase 3 study testing Dapagliflozin 10 mg, Dapagliflozin 5 mg and Saxagliptin 5 mg in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 4 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing… Read more about this study

Who is it for?
Ages 18 to 130 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Dapagliflozin 10 mg, Dapagliflozin 5 mg and Saxagliptin 5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
4 sitesin 2 countries
Study dates
27 Feb 2019to 4 Aug 2020
Phase
Phase 3
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 130 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent before participating in the study
  • Diagnosed with type 2 diabetes mellitus
  • Inadequate glycemic control defined as below:
  • HbA1c ≥ 8.0% and ≤ 11.5% for Stratum A and HbA1c ≥ 7.5% and ≤ 10.5% for Stratum B at screening visit
  • HbA1c ≥ 7.0 and ≤ 10.5% for both strata at Week -2 visit
  • Body mass index ≤ 40.0 kg/m^2

Who cannot join

  • Women of childbearing potential unable or unwilling to use acceptable birth control, or women who are pregnant or breastfeeding
  • History of diabetes insipidus and type 1 diabetes
  • History of diabetic ketoacidosis requiring medical intervention within 1 month prior to screening
  • Subjects with moderate to severe renal impairment (defined as estimate glomerular filtration rate calculated by the MDRD Formula < 60mL/min/1.73 m^2 or serum creatinine ≥ 1.5 mg/dL in males or ≥ 1.4 mg/dL in females) or end-stage renal disease
  • History of unstable or rapidly progressing renal disease
  • Subjects with significant hepatic disease or severe hepatic impairment, or positive serologic evidence of current infectious liver disease
Show all 16Show fewer
  • Prohibited Treatment and Therapies
  • Administration of any anti-hyperglycemic therapy [other than metformin, or Dipeptidyl peptidase-4 (DPP-4) inhibitors] for more than 14 days (consecutive or not) during the 8 weeks prior to screening
  • Any use of Sodium glucose cotransporter 2 (SGLT2) inhibitor within 8 weeks prior to screening
  • Prescription and over-the-counter weight loss medications within 3 months prior to screening
  • Current treatment with potent cytochrome P450 3A4/5 inhibitors
  • Malignancy within 5 years of the screening
  • History of hemoglobinopathy
  • Hematuria (by microscopy) positive at screening visit
  • FPG > 270 mg/dL obtained at open-label period
  • An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded

Trial locations and contacts

4 sites in 2 countries.

4 sites in 2 countries

Thailand2 sites

  • Research Site

    Bangkok, 10330

  • Research Site

    Bangkok, 10400

Other trials in Thailand

Vietnam2 sites

  • Research Site

    Ho Chi Minh City, 10000

  • Research Site

    Ho Chi Minh City, 700000

Other trials in Vietnam

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Safety and Efficacy of Dapagliflozin in Asian Subjects With T2DM and Inadequate Glycemic Control on Metformin and Saxagliptin (DS Navigation)

This is a 24-week, multicenter, randomized, double-blind, double-dummy, placebo-controlled, parallel group, phase 3 study designed to evaluate if the safety and efficacy of dapagliflozin 5 mg or 10 mg added to saxagliptin 5 mg plus metformin is superior to placebo added to saxagliptin 5 mg plus metformin in reducing hemoglobin A1c (HbA1c).

Read the detailed description

This study will be conducted in approximately 36 sites in Asian countries. Approximately 1004 subjects will be screened and 342 randomized. Prior to the screening, subjects of Stratum A should have a stable dose of metformin (≥1500 mg/day or a maximal tolerated dose) for at least 8 weeks. And subjects of Stratum B should have a stable dose of metformin (≥1500 mg/day or a maximal tolerated dose) AND a dipeptidyl peptidase-4 inhibitor at maximum approved dose for at least 8 weeks prior to the screening. Eligible subjects who complete the screening visit will enter the lead-in period, which includes open-label saxagliptin 5 mg and metformin treatment for 16 weeks in Stratum A or 8 weeks in Stratum B. At randomization visit, eligible subjects will be randomized into 1 of 3 treatment groups in a 1:1:1 ratio, receiving blinded dapagliflozin 5 mg, 10 mg or placebo plus metformin and saxagliptin 5 mg treatment for 24 weeks.

Being tested
Dapagliflozin 10 mg, Dapagliflozin 5 mg, Dapagliflozin 10 mg placebo to match, Dapagliflozin 5 mg placebo to match, Saxagliptin 5 mg
Keywords
DPP-4 inhibitor, HbA1c, Incretin, Dapagliflozin
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 10 mgDrug

    10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

  • Dapagliflozin 5 mgDrug

    5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

  • Dapagliflozin 10 mg placebo to matchDrug

    10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

  • Dapagliflozin 5 mg placebo to matchDrug

    5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period

  • Saxagliptin 5 mgDrug

    5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B

  • MetforminDrug

    Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period

Study groups in NCT03608358
Study groupRoleWhat they receive
Dapagliflozin 10 mgExperimentalDapagliflozin 10 mg and dapagliflozin 5 mg placebo to match added to saxagliptin 5 mg and metformin
Receives: Drug: Dapagliflozin 10 mg; Drug: Dapagliflozin 5 mg placebo to match; Drug: Saxagliptin 5 mg; Drug: Metformin
Dapagliflozin 5 mgExperimentalDapagliflozin 5 mg and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin
Receives: Drug: Dapagliflozin 5 mg; Drug: Dapagliflozin 10 mg placebo to match; Drug: Saxagliptin 5 mg; Drug: Metformin
PlaceboPlacebo comparatorDapagliflozin 5 mg placebo to match and dapagliflozin 10 mg placebo to match added to saxagliptin 5 mg and metformin
Receives: Drug: Dapagliflozin 10 mg placebo to match; Drug: Dapagliflozin 5 mg placebo to match; Drug: Saxagliptin 5 mg; Drug: Metformin

What is being measured

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

  1. Mean change from baseline in HbA1c at Week 24

    To compare the mean change from baseline in HbA1c achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment

    Measured: Baseline to Week 24

Secondary outcomes (4)

  1. Mean change from baseline in fasting plasma glucose (FPG) at Week 24

    To compare the mean change from baseline in FPG achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment

    Measured: Baseline to Week 24

  2. Mean change in 2-hour postprandial glucose during a meal tolerance test (2-hour MTT) at Week 24

    To compare the mean change from baseline in 2-hour postprandial glucose from a meal tolerance test (2-hour MTT) achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment

    Measured: Baseline to Week 24

  3. Mean change from baseline in total body weight at Week 24

    To compare the mean change from baseline in total body weight achieved with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin versus placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment

    Measured: Baseline to Week 24

  4. Percent of subjects achieving a therapeutic glycaemic response of HbA1c <7.0% at Week 24

    To compare the proportion of subjects achieving a therapeutic glycaemic response of HbA1c < 7.0% with dapagliflozin 5 mg or dapagliflozin 10 mg added to saxagliptin 5 mg plus metformin vs. placebo added to saxagliptin 5 mg plus metformin after 24 weeks of oral administration of double-blind treatment

    Measured: At week 24

Timeline

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

  1. First posted31 Jul 2018
  2. Study start27 Feb 2019
  3. Primary completion4 Aug 2020
  4. Study completion4 Aug 2020

Why it stopped: Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03608358
Sponsor's protocol ID
D1683C00008
Status last verified
May 2022
First submitted
11 Jul 2018
Last updated
31 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dapagliflozin 10 mg, Dapagliflozin 5 mg and Saxagliptin 5 mg in people with Type 2 Diabetes Mellitus, run by AstraZeneca at 4 sites in 2 countries.

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 6 inclusion and 16 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: stopped early, as of the sponsor's last update on 31 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 4 sites in Thailand, Vietnam. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 was stopped early (reason given: Sponsor decided to stop commercialization of QTERNMet/Qtrilmet and to stop all related ongoing activities/studies for business reasons.). Results are not available in the source record.

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?

Mean change from baseline in HbA1c at Week 24 (time frame: Baseline to Week 24). 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 NCT03608358.

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 31 May 2022.

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