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A Phase III Study to Investigate the Efficacy and Safety of Elecoglipron Alone or in Combination With Dapagliflozin Compared With Placebo in Adults With Type 2 Diabetes Mellitus

ConditionType 2 Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca

About this trial

The purpose of this study is to evaluate the efficacy, safety, and tolerability of elecoglipron alone or in combination with dapagliflozin compared with placebo in adults with type 2 diabetes mellitus (T2DM) inadequately managed with lifestyle management alone or treated with other background glucose-lowering medication.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with Type 2 Diabetes Mellitus (T2DM) for at least 90 days prior to screening

T2DM inadequately managed with lifestyle management alone or on stable treatment with other background glucose-lowering medication

HbA1c value of ≥ 7% to ≤ 10.5% (53 to 91.3 mmol/mol)

Body mass index (BMI) of ≥ 23 kg/m2 at screening

Disqualifiers

Type 1 diabetes, secondary forms of diabetes (including congenital forms), or history of ketoacidosis or hyperosmolar coma

Currently receiving or anticipated to receive, therapeutic intervention for diabetic retinopathy and/or macular edema

Have had more than one episode of severe hypoglycemia within 180 days prior to screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

Clinically significant condition affecting the upper GI tract or chronic use of any medication that affects gastric motility or gastric emptying

Trial design

Design model

Parallel

Treatments tested in this trial

  • Elecoglipron

    Drug

    Elecoglipron is administered orally once daily.

  • Dapagliflozin

    Drug

    Dapagliflozin administered orally once daily.

  • Elecoglipron-matched placebo

    Drug

    A placebo matching elecoglipron, administered orally once daily.

  • Dapagliflozin-matched placebo

    Drug

    A placebo matching dapagliflozin, administered orally once daily.

Treatment groups

800 Participants
are divided into 4 treatment groups
Group A: Elecoglipron dose level 1 + dapagliflozin-matched placeboExperimental treatment 2 interventions
Group B: Elecoglipron dose level 2 + dapagliflozin-matched placeboExperimental treatment 2 interventions
Group C: Elecoglipron (one of the studied dose levels) + dapagliflozinExperimental treatment 2 interventions
Group D: Elecoglipron-matched placebo + dapagliflozin-matched placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from baseline in Hemoglobin A1c (HbA1c)

Time frame
Baseline to Week 40

Secondary outcomes

1

Achievement of HbA1c < 7% (53 mmol/mol)

Time frame
Week 40
2

Achievement of HbA1c ≤ 6.5% (48 mmol/mol)

Time frame
Week 40
3

Percent change in body weight

Time frame
Baseline to Week 40
4

Change from baseline in body weight

Time frame
Baseline to Week 40

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AstraZeneca

Lead sponsor

Source ClinicalTrials.gov
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