DelfaGLP-1 Atlas

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FLAT-SUGAR

CompletedPhase 4Results posted

FLuctuATion Reduction With inSULin and Glp-1 Added togetheR (FLAT-SUGAR)

FLAT-SUGAR: FLuctuATion Reduction With inSULin and Glp-1 Added togetheR

Asset

Exenatide

Subcutaneous · GLP-1 agonist

Listed sites

12

Recruiting sites

—

Enrollment

102

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 25-45•Established CVD•HbA1c 7.5-8.5%

Primary endpoint

•Coefficient of Variation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01524705
Org study ID42178

Timeline

Milestones

Study first posted2012-02-02estimated
Last update posted2023-12-29actual
Results first posted2023-12-29actual
Study start2012-08 (month precision)
Primary completion2014-07actual (month precision)
Study completion2014-07actual (month precision)

Assets

Investigational agents

Exenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age40 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. T2DM for >12 months defined according to current ADA criteria

2. C-peptide >0.5 ng/mL-after informed consent has been signed, samples will be drawn fasting and sent to a central lab

3. Participants must be on insulin therapy. Diabetes, Blood Pressure \& Lipid therapy must be stable (in both dose and agent) for ≥3 months (dose of any 1 drug has not changed by more than 2-fold, \& new agents not been added within the previous 3 months)

4. HbA1c 7.5-8.5% for enrollment

5. Age at enrollment (screening): 40-75 years (inclusive) when there is a history of cardiovascular disease (defined in 'a'), or 55 to 75 years (inclusive) when there is not a history of cardiovascular disease but 2 or more risk factors (with or without treatment) are present (defined in 'b')

a)Established cardiovascular disease defined as presence of one of the following:
i.Previous myocardial infarction (MI). (most recent must be > 3 months prior enrollment)
ii.Previous stroke. (most recent must be >3 months prior enrollment)
iii.History of coronary revascularization (e.g., coronary artery bypass graft surgery, stent placement, percutaneous transluminal coronary angioplasty, or laser atherectomy)(most recent must be > 3 months prior enrollment)
iv.History of carotid or peripheral revascularization (e.g., carotid endarterectomy, lower extremity atherosclerotic disease atherectomy, repair of abdominal aortic aneurysm, femoral or popliteal bypass). (most recent must be >3 months prior enrollment)
v.Angina with either ischemic changes on a resting ECG, or ECG changes on a graded exercise test (GXT), or positive cardiac imaging study
vi.Ankle/brachial index <0.9
vii.LVH with strain by ECG or ECHO
viii.>50% stenosis of a coronary, carotid, renal or lower extremity artery.
ix.Urine albumin to urine creatinine ratio of >30 mg albumin/g creatinine in 2 samples, separated by at least 7 days, within past 12 months) [Target of 50% of study cohort] or
b)Increased CVD risk defined as presence of 2 or more of the following:
i.Untreated LDL-C >130 mg/dL or on lipid treatment
ii.Low HDL-C (<40 mg/dL for men and <50 mg/dL for women)
iii.Untreated systolic BP >140 mm Hg, or on antihypertensive treatment
iv.Current cigarette smoking
v.Body mass index 25-45 (Asian populations 23-45) kg/m2

6. No expectation that participant will move out of clinical center area during the next 8 months, unless move will be to an area served by another trial center

7. Ability to speak \& read English

Exclusion criteria

1. The presence of a physical disability, significant medical or psychiatric disorder; substance abuse or use of a medication that in the judgment of the investigator will affect the use of CGM, wearing of the sensors, Holter or Telemetry monitor, complex medication regimen, or completion of any aspect of the protocol

2. Cannot have had any cardiovascular event or interventional procedure, (MI, Stroke or revascularization) or been hospitalized for unstable angina within the last 3 months

3. Inability or unwillingness to discontinue use of acetaminophen products during CGM use

4. Inability or unwillingness to discontinue use of all other diabetes agents other than insulin \& metformin during trial (including insulin pump participants who will need to convert to BBI)

5. Intolerance of metformin dose <500 mg/day

6. Inability or unwillingness to perform blood glucose testing a minimum of 3 times/per day

7. Creatinine level ≥1.5 for males or 1.4 for females

8. ALT level ≥ 3 times upper limit of normal

9. Current symptomatic heart failure, history of NYHA Class III or IV congestive heart failure at any time, or ejection fraction (by any method) < 25%

10. Inpatient psychiatric treatment in the past 6 months

11. Currently participating in an intervention trial

12. Chronic inflammatory diseases, such as collagen vascular diseases or inflammatory bowel disease

13. History of pancreatitis

14. BMI >45kg/m2

15. For females, pregnant or intending to become pregnant during the next 7 months

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
2
Weight & body composition
1
Safety / tolerability / PK
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Weight Change During Trial

Time frame:Baseline vs 26 weeks

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (mean), kg95% CI
Insulin Glargine, Metformin, Exenatide-4.8—
Insulin Glargine, Metformin, Prandial Insulin0.7—
p<0.001Wilcoxon (Mann-Whitney)

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint/low confidence

Coefficient of Variation at 26 Weeks Minus Coefficient of Variation at Baseline

Time frame:At baseline, 6 months of intervention

change from baseline, improvement

Posted result

GroupValue (mean), percentage95% CI
Insulin Glargine, Metformin, Exenatide-2.43—
Insulin Glargine, Metformin, Prandial Insulin0.44—
Wilcoxon—p<0.024Wilcoxon (Mann-Whitney)
Other/protocol endpoint

HbA1C Levels

Time frame:Baseline vs 26 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (mean), % of HbA1C95% CI
Insulin Glargine, Metformin, Exenatide7.1—
Insulin Glargine, Metformin, Prandial Insulin7.2—
p0.77Wilcoxon (Mann-Whitney)

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of Participants With Hypoglycemia

Time frame:26 weeks

Documented hypoglycemia

event count, event

componentsDocumented hypoglycemia, Severe hypoglycemia

Posted result

GroupValue (count_of_participants), Participants95% CI
Insulin Glargine, Metformin, Exenatide0—
Insulin Glargine, Metformin, Prandial Insulin0—

Publications (46)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.