Impact on Glycemic Variability in Newly Onset T2DM Patients Initiating Dapagliflozin Plus Metformin Versus Metformin Alone

NCT04090580 | Completed Phase 3 Results

• 1 other identifier: 3089
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the effect of Dapagliflozin added to Metformin vs Metformin alone on blood sugar fluctuations of adults with a recent diagnosis of Type 2 Diabetes (T2D). The duration of the protocol will be 12 weeks. Continuous glucose monitoring will be measured before and at the end of the intervention. The questions this protocol will answer include:

• Is there a difference in blood sugar fluctuations when Dapagliflozin is added to Metformin compared with Metformin alone in adults with type 2 Diabetes?
• Does Dapagliflozin added to Metformin improve blood glucose control in patients with type 2 Diabetes?

Conditions

Type 2 Diabetes

Keywords

dapagliflozin; glycemic variability; MAGE; DIABETES MELLITUS

Outcome Measures

Primary Outcomes (7)

• ΔHbA1c

  Difference between serum HbA1c before treatment (W0) and at the end of intervention (W12) expressed in percentage.

  12 weeks

• ΔMAGE

  ● Calculation of Mean Amplitude of Glucose Excursion (MAGE): * In the first step, all local maximum/minimum values are determined. * The next step is an evaluation of maximum/minimum pairs against the standard deviation (SD). * If the difference from minimum to maximum is greater than the SD, this variation from the mean measurement is retained. * If the local maximum/minimum is less than 1 SD, it is excluded from further calculations. * These channels are retained and summed to achieve the MAGE

  12 weeks

• Δweight

  The difference between weight before the treatment period (W0) and the end of the intervention is calculated and expressed as delta for results interpretation.

  12 weeks

• ΔTIR %Target 70-180 mg/dL

  Time in range is defined as the percentage of time that the patient's blood glucose is between 70-180 mg/dL.

  12 weeks

• Δinsulin

  Delta insulin is defined as the difference in insulin plasma concentration before treatment (W0) and at the end of the intervention (W12).

  12 weeks

• Δsystolic Blood Pressure

  It is defined as the difference in systolic blood pressure before treatment (W0) and after the end of intervention (W12)

  12 weeks

• ΔTriglycerides mg/dL

  It is defined as the difference in triglycerides plasma concentration before and at the end of intervention (W12-W0)

  12 weeks

Secondary Outcomes (1)

• ΔUric Acid

  12 weeks

Study Arms (2)

DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks

EXPERIMENTAL

Subjects enrolled will be randomized 1:1 to receive a daily dosage of 10 mg dapagliflozin and 2000 mg metformin for 12 weeks

Diagnostic Test: Continuous glucose monitoring

METFORMIN 2000 mg/day for 12 weeks

ACTIVE COMPARATOR

Subjects enrolled will be randomized 1:1 to receive a daily dosage of 2000 mg Metformin for 12 weeks

Diagnostic Test: Continuous glucose monitoring

Interventions

Continuous glucose monitoring DIAGNOSTIC_TEST

Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks or 2000 mg metformin. Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded. Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit).

DAPAGLIFLOZIN 10 mg/day + METFORMIN 2000 mg/day for 12 weeks; METFORMIN 2000 mg/day for 12 weeks

Eligibility Criteria

• Age: 18 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects \> 18-77 years-old
• Both Male and female
• Hba1c ≥ 7.5 % and ≤12%
• BMI \> 25 and \<45 kg/m2
• Type 2 diabetes diagnosis, drug-naive

You may not qualify if:

• Hba1c \> 12%
• Creatinine clearance CKD-EPI: \< 60 mL/min
• LADA or Type 1 diabetes
• Gestational diabetes
• Clinically significant disease like: hepatic, hematological, oncological, psychiatric or rheumatic disease.
• Symptoms of marked uncontrolled diabetes: (marked poliuria or polidipsia + 10% weight loss prior the last 3 months enrollement)
• Known hypersensitivity to dapagliflozin or any of the excipients of the product
• eGFR persistently \<45 mL/min/1.73 m2
• Unstable or rapidly progressing renal disease
• Patients with severe hepatic impairment (Child-Pugh class C)
• Any major CV event/Vascular Disease within 3 months prior to signing the consent at enrollment, as assessed by the investigator
• For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead
• AstraZeneca: collaborator

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán ''INCMNSZ''

Mexico City, 14080, Mexico

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Miguel Ángel Gómez Sámano
• Organization: Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán". Vasco de Quiroga 15, Belisario Domínguez Secc 16, Tlalpan, 14080, CDMX, Mexico. Department of endocrinology and lipid metabolism

miguel.gomezs@incmnsz.mx

+52 1 55 59939816

Study Officials

• Miguel Angel Gomez Samano, MD

  Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Evaluation of efficacy between Dapagliflozin with Metformin (Intervention) vs Metformin alone (Standard of care)

Study Record Dates

• First Submitted: September 11, 2019
• First Posted: September 16, 2019
• Study Start: October 27, 2019
• Primary Completion: March 6, 2021
• Study Completion: March 30, 2021
• Last Updated: May 22, 2025
• Results First Posted: May 22, 2025

Record last verified: 2025-05

Locations

ME (1)