Type 2 DiabetesPhase 4AMAZINGNCT02142309
Glycemic Durability After Metformin Failure
A Phase 4 study testing Glimepiride, Vildagliptin and Pioglitazone in people with Type 2 Diabetes, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
Trial summary
Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of <7%. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Glimepiride, Vildagliptin and Pioglitazone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 2 sitesItaly
- Study dates
- Oct 2005to Jan 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly-diagnosed, type 2 diabetic patients, failing to diet
Who cannot join
- Suspected type 1 diabetes or secondary diabetes resulting from specific causes
- Current or previous (within past 3 months) treatment with any investigational drug
- Any major cardiovascular event in previous year
- Plans for pregnancy during the course of the study for women of childbearing potential
- Serum creatinine level >1.3 mg/dL in women and >1.4 mg/dL in men
- History of cancer, other than nonmelanoma skin cancer, that required therapy in the 5 years before randomization
- Treatment with oral, loal, systemic glucocorticoids 14. Treatment with atypical antipsychotics
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Recruiting
Katherine Esposito
Naples, Naples, 80138
Maria Ida Maiorino, MD, mariaida.maiorino@unina2.it
Giuseppe Bellastella, MD
- Active, not recruiting
Department of Geriatrics and Metabolic Diseases
Naples, 80138
About this study
Official title: Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes
Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of <7%.
AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.
Read the detailed description
- Source data verification: paper or electronic medical records.
- Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle
- Conditions
- Type 2 Diabetes
- Being tested
- Glimepiride, Vildagliptin, Pioglitazone, Canagliflozin
- 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.
GlimepirideDrug
Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
VildagliptinDrug
Reduce to 50 mg if estimated glomerular filtration rate (eGFR) <45 mL/min
PioglitazoneDrug
Start with 15 mg/day and advance to 30 mg/day
CanagliflozinDrug
Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
| Study group | Role | What they receive |
|---|---|---|
| Glimepiride | Experimental | up to 4 mg/day Receives: Drug: Glimepiride |
| Vildagliptin | Experimental | 50 mg bid Receives: Drug: Vildagliptin |
| Pioglitazone | Experimental | up to 30 mg/day Receives: Drug: Pioglitazone |
| Canagliflozin | Experimental | 300 mg/day Receives: Drug: Canagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is maintenance of metabolic control (glycemic durability), defined as time to primary failure with a HbA1c value >7% on maximally tolerated doses of the assigned drug.
Measured: Six years
Secondary outcomes (1)
Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2014 (estimated)
- Study startOct 2005
- Primary completionOct 2015
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dario Giugliano, University of Campania Luigi Vanvitelli
- Investigators
- Dario Giugliano, MD PHD, Principal investigator, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02142309
- Sponsor's protocol ID
- DGM 7-2006
- Acronym
- AMAZING
- Status last verified
- Nov 2015
- First submitted
- 26 Apr 2014
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Glimepiride, Vildagliptin, Pioglitazone and Canagliflozin on Durability of Glycemic Control After Metformin Failure in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02142309
- Acronym / sponsor ID
- AMAZING / DGM 7-2006
- Conditions
- Type 2 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Oct 2015 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 20 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Type 2 diabetes is epidemic and its treatment has become more and more difficult. Consensus algorithms have been developed to help clinicians to select among the numerous medications and their combinations for achieving and maintaining a target glycated hemoglobin A1c (HbA1c) of <7%.
AMAZING, a pragmatic clinical trial, aims to compare commonly used oral diabetes medications, when combined with metformin, on glycemia-lowering effectiveness.
Detailed description
- Source data verification: paper or electronic medical records.
- Statistical analysis: All analyses will compare the randomly assigned treatment groups under the intention- to-treat principle
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Glimepiride | Experimental | Drug: Glimepirideup to 4 mg/day |
| Vildagliptin | Experimental | Drug: Vildagliptin50 mg bid |
| Pioglitazone | Experimental | Drug: Pioglitazoneup to 30 mg/day |
| Canagliflozin | Experimental | Drug: Canagliflozin300 mg/day |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Newly-diagnosed, type 2 diabetic patients, failing to diet
Key exclusion criteria (7 listed)
- Suspected type 1 diabetes or secondary diabetes resulting from specific causes
- Current or previous (within past 3 months) treatment with any investigational drug
- Any major cardiovascular event in previous year
- Plans for pregnancy during the course of the study for women of childbearing potential
- Serum creatinine level >1.3 mg/dL in women and >1.4 mg/dL in men
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 |
|---|---|---|
| GlimepirideWeekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily | Drug | Glimepiride |
| VildagliptinReduce to 50 mg if estimated glomerular filtration rate (eGFR) <45 mL/min | Drug | Vildagliptin |
| PioglitazoneStart with 15 mg/day and advance to 30 mg/day | Drug | Pioglitazone |
| CanagliflozinStart with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring | Drug | Canagliflozin |
Primary outcome
The primary outcome is maintenance of metabolic control (glycemic durability), defined as time to primary failure with a HbA1c value >7% on maximally tolerated doses of the assigned drug.
Time frame: Six years
1 secondary outcome
Continuous glucose monitoring for 72 consecutive hours at least once each year of follow-up
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2016.
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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.
Dario Giugliano, MD PHD principal investigator
University of Campania Luigi Vanvitelli
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 Glimepiride, Vildagliptin and Pioglitazone in people with Type 2 Diabetes, run by University of Campania Luigi Vanvitelli at 2 sites in Italy.
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Apr 2016. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dario Giugliano, MD (39 081 5665054, dario.giugliano@unina2.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is maintenance of metabolic control (glycemic durability), defined as time to primary failure with a HbA1c value >7% on maximally tolerated doses of the assigned drug. (time frame: Six years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.