PrediabetesPhase 4NCT02700334

Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

A Phase 4 study testing Dapagliflozin in people with Prediabetes and Impaired Fasting Glucose, run by University of Guadalajara at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM). Read more about this study

Who is it for?: Ages 30 to 60 years
Conditions the study is for: Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
What is being tested?: Dapagliflozin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteMexico
Study dates: Oct 2016to Feb 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Patients both sexes
Age between 30 and 60 years
Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
Informed consent signed

Who cannot join

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to ingredients of intervention
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased
Diabetes diagnosis

Show all 12Show fewer

Previous treatment for glucose
Body Mass Index ≥35 kg/m2
Triglycerides ≥500 mg/dL
Total cholesterol ≥240 mg/dL
Low density lipoprotein (c-LDL) ≥190 mg/dL
Blood Pressure ≥140/90 mmHg

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Intstituto de Terapeútica Experimental y Clínica. Centro Universitario de Ciencias de la Salud. Universidad de Guadalajara
Guadalajara, Jalisco, 44340

Other trials in Mexico

About this study

Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM.

The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes.

The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.

Read the detailed description

A randomized, double-blind, placebo-controlled clinical trial in 24 patients with a diagnosis of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.

They will be assigned randomly two groups of 12 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.

There will be calculated Area Under the Curve of glucose and insulin, total insulin secretion (Insulinogenic index), first-phase of insulin secretion (Stumvoll index) and insulin sensitivity (Matsuda index).

This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

Statistical analysis will be presented through measures of central tendency and dispersion, average and deviation standard for quantitative variables; frequencies and percentages for variable qualitative. Qualitative variables will be analyzed by X2, will be used for differences inter-group Mann-Whitney U Test and Wilcoxon Test for the within-groups differences. It will be considered statistical significance p ≤0.05.

This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Conditions: Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
Being tested: Dapagliflozin, Placebo
Keywords: Prediabetes, Impaired fasting glucose, Hyperglycemia, Impaired glucose tolerance, Glucose intolerance, Dapagliflozin, Sodium glucose cotransporter 2 inhibitor, SGLT2
Medical subject headings: Prediabetic State, Glucose Intolerance, Hyperglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DapagliflozinDrug
Also called Forxiga
10 mg, one per day before breakfast during 12 weeks.
PlaceboDrug
Also called Calcined magnesium
one per day before breakfast during 12 weeks.

Study groups in NCT02700334
Study group	Role	What they receive
Dapagliflozin	Experimental	Dapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks. Receives: Drug: Dapagliflozin
Placebo	Placebo comparator	Placebo capsules, one per day before breakfast during 12 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Fasting Glucose
The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Measured: Fasting Glucose levels at week 12
Postprandial Glucose
Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
Measured: Postprandial Glucose levels at Week 12
First Phase of Insulin Secretion
The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis.
First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Measured: First Phase of Insulin Secretion at Week 12
Total Insulin Secretion
Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at week 12.
The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus.
Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Measured: Total Insulin Secretion at Week 12
Insulin Sensitivity
Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at week 12.
Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity
Measured: Insulin Sensitivity at Week 12
Glycosylated Hemoglobin
Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12
Measured: Glycosylated Hemoglobin at Week 12

Secondary outcomes (11)

Body Weight
The body weight will be measured with a bioimpedance balance and the entered values reflect the body weight at week 12
Measured: Body Weight at Week 12
Body Mass Index
Body Mas Index will be calculated with the Quetelet index formula and the entered values reflect the body mass index at week 12
Measured: Body Mass Index at Week 12
Total Cholesterol
Total cholesterol levels will be evaluated by enzymatic/colorimetric techniques and the entered values reflect the total cholesterol level at week 12
Measured: Total Cholesterol levels at Week 12
Triglycerides
Triglycerides levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the triglycerides level at week 12
Measured: Triglycerides levels at Week 12
High Density Lipoprotein Cholesterol (HDL-c)
HDL-c levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the c-HDL level at week 12
Measured: HDL-c levels at Week 12
Alanine Aminotransferase (ALT)
ALT levels will be evaluated with enzymatic/colorimetric techniques at week 12
Measured: ALT levels at Week 12
Aspartate Aminotransferase (AST)
AST levels will be evaluated with enzymatic/colorimetric techniques at week 12
Measured: AST levels at Week 12
Creatinine
Creatinine levels will be evaluated with enzymatic/colorimetric techniques at week 12
Measured: Creatinine levels at Week 12
Uric Acid
Uric acid levels will be evaluated with enzymatic/colorimetric techniques at week 12
Measured: Uric Acid levels at Week 12
Systolic Blood Pressure
Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Measured: Systolic Blood Pressure at Week 12
Diastolic Blood Pressure
Systolic Blood pressure will be measured with a digital sphygmomanometer and the entered values reflect the blood pressure at week 12
Measured: Diastolic Blood Pressure at Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2016Feb 2017

First posted7 Mar 2016 (estimated)
Study startOct 2016
Primary completionJan 2017
Study completionFeb 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PrediabetesStudies 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: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02700334
Sponsor's protocol ID: DAPA-PREDIABETES
Status last verified: Oct 2020
First submitted: 23 Feb 2016
Last updated: 28 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
ClinicalTrials.gov ID: NCT02700334
Acronym / sponsor ID: DAPA-PREDIABETES
Conditions: Prediabetes, Impaired Fasting Glucose, Impaired Glucose Tolerance
Keywords: Prediabetes, Impaired fasting glucose, Hyperglycemia, Impaired glucose tolerance, Glucose intolerance, Dapagliflozin, Sodium glucose cotransporter 2 inhibitor, SGLT2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: University of GuadalajaraUniversity, hospital or other
Study start: Oct 2016 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Feb 2017 (actual)
First posted: 7 Mar 2016 (estimated)
Results: Posted 8 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes.

The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.

Detailed description

A randomized, double-blind, placebo-controlled clinical trial in 24 patients with a diagnosis of prediabetes in accordance with the American Diabetes Association (ADA) without treatment.

They will be assigned randomly two groups of 12 patients each to receive 10 mg of Dapagliflozin (Forxiga, Astra Zeneca) or placebo, one per day before breakfast during 12 weeks.

This protocol it's already approved by the local ethics committee and written informed consent it's going to be obtained from all volunteers.

This protocol was approved by a local ethics committee and written informed consent will be obtained from all volunteers.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Dapagliflozin	Experimental	Drug: DapagliflozinDapagliflozin capsules, 10 mg, one per day before breakfast during 12 weeks.
Placebo	Placebo comparator	Drug: PlaceboPlacebo capsules, one per day before breakfast during 12 weeks.

Who may qualify

Ages: 30 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Patients both sexes
Age between 30 and 60 years
Diagnosis of prediabetes according ADA criteria (fasting blood glucose levels between 100-126 mg/dl; postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral glucose between 140-199 mg/dl; or glycosylated hemoglobin between 5.7-6.4%)
Informed consent signed

Key exclusion criteria (12 listed)

Women with confirmed or suspected pregnancy
Women under lactation and/or puerperium
Hypersensibility to ingredients of intervention
Physical impossibility for taking pills
Known uncontrolled renal, hepatic, heart or thyroid diseased

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
DapagliflozinAlso: Forxiga10 mg, one per day before breakfast during 12 weeks.	Drug	Dapagliflozin
PlaceboAlso: Calcined magnesiumone per day before breakfast during 12 weeks.	Drug	Placebo

Primary outcome

Fasting Glucose
Time frame: Fasting Glucose levels at week 12
The fasting glucose levels will be evaluated with enzymatic/colorimetric techniques and the entered values reflect the fasting glucose level at week 12
Postprandial Glucose
Time frame: Postprandial Glucose levels at Week 12
Postprandial glucose will be evaluated after a oral glucose tolerance test with enzymatic/colorimetric techniques and the entered values reflect the insulin sensitivity at week 12
First Phase of Insulin Secretion
Time frame: First Phase of Insulin Secretion at Week 12
The first phase of insulin secretion will be calculated with Stumvoll index and the entered values reflect the frst phase of insulin secretion at week 12. Human studies support the critical physiologic role of the first-phase of insulin secretion in the maintenance of postmeal glucose homeostasis. First phase of insulin secretion was estimated using the Stumvoll index (1283+ 1.829 x insulin 30' - 138.7 x glucose 30' + 3.772 x insulin 0'), the entered values reflect the first phase of insulin secretion
Total Insulin Secretion
Time frame: Total Insulin Secretion at Week 12
Total insulin secretion will be calculated with insulinogenic index and the entered values reflect the total insulin secretion at week 12. The insulinogenic index is a ratio that relates enhancement of circulating insulin to the magnitude of the corresponding glycemic stimulus. Total insulin secretion was calculated with the insulinogenic index (ΔABC insulin/ΔABC glucose), the entered values reflect the total insulin secretion
Insulin Sensitivity
Time frame: Insulin Sensitivity at Week 12
Insulin sensitivity will be calculated with Matsuda index and the entered values reflect the insulin sensitivity at week 12. Matsuda Index value is used to indicate insulin resistance on diabetes. Insulin sensitivity was calculated with Matsuda index [10,000 / √glucose 0' x insulin 0') (mean glucose oral glucose tolerance test (OGTT) x mean insulin OGTT)]. The entered values reflect the insulin sensitivity
Glycosylated Hemoglobin
Time frame: Glycosylated Hemoglobin at Week 12
Glycosylated hemoglobin will be evaluated by ELISA and the entered values reflect the glycosylated hemoglobin at week 12

11 secondary outcomes

Body Weight
Time frame: Body Weight at Week 12
Body Mass Index
Time frame: Body Mass Index at Week 12
Total Cholesterol
Time frame: Total Cholesterol levels at Week 12
Triglycerides
Time frame: Triglycerides levels at Week 12
High Density Lipoprotein Cholesterol (HDL-c)
Time frame: HDL-c levels at Week 12
Alanine Aminotransferase (ALT)
Time frame: ALT levels at Week 12
Aspartate Aminotransferase (AST)
Time frame: AST levels at Week 12
Creatinine
Time frame: Creatinine levels at Week 12
Uric Acid
Time frame: Uric Acid levels at Week 12
Systolic Blood Pressure
Time frame: Systolic Blood Pressure at Week 12
Diastolic Blood Pressure
Time frame: Diastolic Blood Pressure at Week 12

Results and safety

Results posted to the registry on 8 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Dapagliflozin	12	12
Placebo	12	12

Primary outcome: Fasting Glucose

Time frame: Fasting Glucose levels at week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Dapagliflozin n = 12	Placebo n = 12
Value	5.1 (0.3)	5.9 (0.5)

Dapagliflozin vs Placebo: p = 0.005, Wilcoxon (Mann-Whitney)

Primary outcome: Postprandial Glucose

Time frame: Postprandial Glucose levels at Week 12. Mean (Standard Deviation). Unit: mmol/L

Measure	Dapagliflozin n = 12	Placebo n = 12
Value	8.4 (1.5)	8.7 (2.7)

Dapagliflozin vs Placebo: p = 0.093, Wilcoxon (Mann-Whitney)

Primary outcome: First Phase of Insulin Secretion

Time frame: First Phase of Insulin Secretion at Week 12. Mean (Standard Deviation). Unit: index

Measure	Dapagliflozin n = 12	Placebo n = 12
Value	1096 (388)	1379 (566)

Dapagliflozin vs Placebo: p = 0.878, Wilcoxon (Mann-Whitney)

Primary outcome: Total Insulin Secretion

Time frame: Total Insulin Secretion at Week 12. Mean (Standard Deviation). Unit: index

Measure	Dapagliflozin n = 12	Placebo n = 12
Value	0.50 (0.18)	0.67 (0.33)

Dapagliflozin vs Placebo: p = 0.959, Wilcoxon (Mann-Whitney)

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected throughout the study (12 weeks). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dapagliflozin	0 of 12 (0%)	7 of 12 (58.3%)	0 of 12
Placebo	0 of 12 (0%)	6 of 12 (50%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

MANUEL GONZALEZ, PhD principal investigator

University of Guadalajara

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Dapagliflozin in people with Prediabetes and Impaired Fasting Glucose, run by University of Guadalajara at 1 site in Mexico.

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 4 inclusion and 12 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: finished, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Glucose (time frame: Fasting Glucose levels at week 12). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02700334.

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 28 Oct 2020.