Primary outcomeMean· at the end of the study (3 years)
HbA1c Level
| Group | Value (percentage of glycated hemoglobin) | Spread |
|---|---|---|
| Triple Therapy | 6.9 | 0.1 |
| Conventional Therapy | 6.4 | 0.1 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataDurability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 318 participants (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
United States
- Start
- Jan 2009
- Primary completion
- 3 Feb 2023
- Completion
- 3 Feb 2023
- First posted
- 21 Apr 2010 (estimated)
- Last update posted
- 5 Sept 2024
- Conditions
- Diabetes
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201020152020
- Ph 4
Durability of Combination Therapy With Exenatide/Pioglitazone/Metformin vs. Conventional Therapy in New Onset T2DM
NCT01107717Jan 2009 to 3 Feb 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
Type 2 diabetes is a systemic metabolic disease with significant morbidity and mortality due to damaging blood vessels. Increased blood sugar level is a hallmark of diabetes and is an contributes to the development of many of its complications. Multiple defects, e.g. impaired insulin secretion and impaired insulin action, contribute to the development of the disease. The aim of this study is to test the efficacy and durability of combination of drugs which correct the defects that lead to the development of diabetes on achieving adequate and durable control of blood sugar levels. Achieving adequate and durable control of blood sugar will prevent many of diabetes complications.
Interventions
- metformin\pioglitazone\exenatideDrug
- metformin, glyburide and glargineDrug
Arms2
Experimental
Triple Therapy
initiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed
Active comparator
conventional therapy
sequential addition of metformin, glyburide and basal insulin
Primary outcomes1
Outcomes the sponsor listed as primary.
HbA1c Level
Time frame · at the end of the study (3 years)
Registry description
subjects will be followed for 3 years and the HbA1c measured at this time to provide the values for each arm as defined for the primary outcome of the study
Secondary outcomes(2)
Treatment Failure
Time frame · 3 years
Registry description
Number of participants with HbA1c\>6.5% at 3 years
Percentage of Patients With Reported Hypoglycemic Events
Time frame · during the entire study (3 years)
Registry description
asymptomatic hypoglycemic events with documented PGC \< 60 mg/dl and sympotomatic hypoglycemia
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(2)
Secondary outcomeNumber· 3 years
Treatment Failure
| Group | Value (number of participants) |
|---|---|
| Triple Therapy | 33 |
| Conventional Therapy | 59 |
Secondary outcomeCount of participants· during the entire study (3 years)
Percentage of Patients With Reported Hypoglycemic Events
| Group | Value (Participants) |
|---|---|
| Triple Therapy | 14 |
| Conventional Therapy | 52 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Triple Therapyinitiation a combination of metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) at the time diabetes is diagnosed metformin\\pioglitazone\\exenatide: metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c \< 6.5% | 0 / 103 | 0 / 103 | 44 / 103 |
| Conventional Therapysequential addition of metformin, glyburide and basal insulin metformin, glyburide and glargine: subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c \< 6.5% | 2 / 114 | 0 / 114 | 53 / 114 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- ResultAbdul-Ghani M, Puckett C, Adams J, Khattab A, Baskoy G, Cersosimo E, Triplitt C, DeFronzo RA. Durability of Triple Combination Therapy Versus Stepwise Addition Therapy in Patients With New-Onset T2DM: 3-Year Follow-up of EDICT. Diabetes Care. 2021 Feb;44(2):433-439. doi: 10.2337/dc20-0978. Epub 2020 Dec 3. PMID 33273042
- DerivedAbdul-Ghani M, Puckett C, Abdelgani S, Merovci A, Lavrynenko O, Adams J, Triplitt C, DeFronzo RA. Glycemic and non-glycemic benefits of initial triple therapy versus sequential add-on therapy in patients with new-onset diabetes: results from the EDICT study. BMJ Open Diabetes Res Care. 2025 Apr 27;13(2):e004981. doi: 10.1136/bmjdrc-2025-004981. PMID 40288809
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 80 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria:
* subjects with type 2 diabetes diagnosed during the past 2 years,
* above 18 years of age,
* drug naive, or have been on metformin less than 3 months
Exclusion Criteria:
* subjects with type 1 diabetes or GAD positive subjects or subjects with long standing diabetes (\>2 years) or subjects who are not drug naive or have been on metformin more than 3 months.
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