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Type 2 DiabetesPhase 4SPECIFYNCT02280486

Efficacy and Safety of Saxagliptin VS. Glimepiride in Chinese T2DM Patients Controlled Inadequately With Metformin

A Phase 4 study testing Saxagliptin and Glimepiride in people with Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

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

This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy. Read more about this study

Who is it for?
Ages 25 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Saxagliptin and Glimepiride
Could I receive a placebo?
No, everyone receives an active treatment
How many people
388 participants
Where
1 siteChina
Study dates
Jan 2015to Oct 2017
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 25 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • For inclusion in the study subjects should fulfill the following criteria:
  • Provision of informed consent prior to any study specific procedures
  • Type2 diabetic patients had been on stable, maximum tolerated doses of metformin (≧1500mg/d, ≧8 weeks)
  • Male or female age ≧ 25 years and ≦75 years old
  • HbA1c ≧7.0 and ≦9.5%
  • BMI ≧ 20 and ≦ 30 kg/m2

Who cannot join

  • Subjects should not enter the study if any of the following exclusion criteria are fulfilled:
  • Known or suspected allergy to trial products or related products.
  • Impaired renal function defined as serum-creatinine ≥ 1.5 mg/dL (≥ 132.6 μmol/l).
  • Acute or chronic disease which may cause tissue hypoxia such as cardiac or respiratory failure, shock.
  • Hepatic insufficiency, acute alcohol intoxication, alcoholism.
  • Subjects has a clinically significant, active (or over the past 12 months) cardiovascular history (including a history of myocardial infarction (MI), arrhythmias or conduction delays on ECG, unstable angina, or decompensated heart failure (New York Heart Association-class Ⅲ and Ⅳ).
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  • Proliferative retinopathy or muscular oedema requiring acute treatment.
  • Lactation.
  • Pregnant or positive pregnancy test at screening, nursing mother, or unwillingness to use adequate contraception (adequate contraceptive measures are sterilization, intrauterine device, oral contraceptives or barrier methods).
  • Treatment with systemic corticosteroids within the past two months prior to screening.
  • Tested positive for glutamic acid decarboxylase antibody.
  • Receipt of any investigational drug within 1 month prior to this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • at Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

    Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Efficacy and Safety of Saxagliptin and Glimepiride in Chinese Patients With Type 2 Diabetes Controlled Inadequately With Metformin Monotherapy (SPECIFY Study) : a 48-week, Multi-center, Randomized, Open-label Trial

This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Read the detailed description

This is a multi-centre, open-label, randomized, parallel trial to investigate the efficacy and safety profile of saxagliptin and glimepiride treatment in patients with type 2 diabetes inadequately controlled with metformin monotherapy.

Screening will be made to select eligible participants before intervention. The trial will include 1-week run-in period of stable doses of metformin (1500mg) and 48-week treatment period. After the run-in period, patients were randomly assigned to one of two groups for antihyperglycaemic therapies for a total of 48-weeks: saxagliptin and glimepiride. The treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the study. Glimepiride will be initially treated with 1 mg every morning, and further titrated up at 4-week intervals until to reach the target fasting blood glucose (FPG).As to Glimepiride groups, if the fasting blood glucose dose not achieved the target after the maximal doses, maintain the maximal doses(6mg per day) until the completion of the study.Meanwhile, participants in both groups should take metformin 1500mg per day throughout the whole 48 weeks. At the end of the study, data will be collected and analyzed.

Conditions
Type 2 Diabetes
Being tested
Saxagliptin, Glimepiride
Keywords
saxagliptin, glimepiride, metformin monotherapy
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.

  • SaxagliptinDrug

    Also called Onglyza，Astrazeneca

    5 mg/d

  • GlimepirideDrug

    Also called Amaryl，Sanofi-Aventis

    1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg

Study groups in NCT02280486
Study groupRoleWhat they receive
SaxagliptinActive comparatorThe treatment of saxagliptin will be initiated and maintained at 5mg every morning until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
Receives: Drug: Saxagliptin; Drug: Glimepiride
GlimepirideActive comparatorGlimepiride will be initially treated with 1 mg every morning to a dose of 6 mg/day.a.m. Every 4-week the subjects will be evaluated whether reach the target fasting plasma glucose (assayed by finger-stick ≦6.1 mmol/l ). If the fasting blood glucose not achieved the target at the maximum dose, maintain the maximum dose(6mg/d) until the completion of the test.Meanwhile,subjects will be instructed to take stable doses of metformin (1500mg/d) through the whole trial.
Receives: Drug: Saxagliptin; Drug: Glimepiride

What is being measured

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

  1. Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0%

    Compare the proportion of subjects after 48-week treatment achieving HbA1c<7.0%, with no hypoglycemia and no body weight gain (defined as glucose < 3.9 mmol/L with or without symptoms and weight gain < 3.0%).

    Measured: Change from Baseline after 48 weeks treatment

Secondary outcomes (4)

  1. The change in blood glucose fluctuations of subjects.

    30 subjects of each group would be randomly chosen to evaluate blood glucose fluctuations by continuous glucose monitoring system (CGMS) before and after 48 weeks treatment.

    Measured: Change from Baseline after 48 weeks treatment

  2. The improvement in beta-cell function of subjects

    All subjects would be tested in fasting proinsulin, proinsulin/insulin ratio, true insulin and C-peptide during standard meal test (75-gram instant noodles) before and after 48 weeks treatment.

    Measured: Change from Baseline after 48 weeks treatment

  3. The change in body composition of subjects.

    All subjects would be measured by their weight (WT), body mass index (BMI) and waist-hip ratio (WHR) every four weeks until the end of 48 weeks treatment.

    Measured: Change from Baseline after 48 weeks treatment

  4. Safety and tolerability of saxagliptin vs. glimepiride measured by adverse events, serious adverse events (SAEs); laboratory assessments (biochemistry, lipids, blood and urine routine tests

    The proportion of AEs and SAEs would be measured.Incidence of hypoglycemia episodes (defined as symptoms with glucose < 3.1 mmol/L);adverse events (AEs);serious adverse events (SAEs);laboratory assessments (biochemistry, lipids, blood and urine routine tests);other safety and tolerability parameters (ECG, vital signs, physical examination).

    Measured: Change from Baseline after 48 weeks treatment

Timeline

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

  1. First posted31 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionOct 2016
  4. Study completionOct 2017

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02280486
Sponsor's protocol ID
ISSSAXA0014
Acronym
SPECIFY
Status last verified
Mar 2018
First submitted
23 Oct 2014
Last updated
23 Jul 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Gu T, Ma J, Zhang Q, Zhu L, Zhang H, Xu L, Cheng J, Shi B, Li D, Shao J, Sun Z, Zhong S, Bi Y, Zhu D. Comparative effect of saxagliptin and glimepiride with a composite endpoint of adequate glycaemic control without hypoglycaemia and without weight gain in patients uncontrolled with metformin therapy: Results from the SPECIFY study, a 48-week, multi-centre, randomized, controlled trial. Diabetes Obes Metab. 2019 Apr;21(4):939-948. doi: 10.1111/dom.13605. Epub 2019 Jan 4.

    PubMed 30520221

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Saxagliptin and Glimepiride in people with Type 2 Diabetes, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.

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 12 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 23 Jul 2018. 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 China. 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?

Proportion of subjects achieving glycemic response defined as Glycosylated hemoglobin (HbA1c) < 7.0% (time frame: Change from Baseline after 48 weeks treatment). 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 NCT02280486, 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 23 Jul 2018.

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