Diabetes Mellitus, Type 2Phase 1NCT04504045

Metformin's Effect on Drug Metabolism in Patients With Type 2 Diabetes

A Phase 1 study testing Metformin, Caffeine and Efavirenz in people with Diabetes Mellitus, Type 2, run by University of Southern Denmark at 1 site in Denmark.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Metformin, Caffeine and Efavirenz
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteDenmark
Study dates: 1 Sep 2020to 10 May 2022
Phase: Phase 1
Are there results?: None posted in the registry

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 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Type 2 diabetes, not treated metformin.
Hemoglobin 1Ac (HbA1c): ≥48 mmol/mol
Age: 18-75 years
Body Mass Index (BMI) ≤ 40 kg/m2
Estimated Glomerular Filtration Rate (eGFR) > 60 mL/min
Alanine Aminotransferase (ALAT), bilirubin and hemoglobin within reference range or clinically insignificant differ from this.

Who cannot join

Acute or chronic infection or inflammation
Active cancer
Glutamic acid decarboxylase (GAD)-antibodies
Known hypersensitivity to one or several of the drugs
Intake of medications which can influence the safety of the patient or the results of the study
Alcohol consumption above the limits recommended by the Danish Health Authorities (Men 14 units/week, women 7 units/week)
Participation in other trials with interventions.
Women: Positive pregnancy test at inclusion or on one of the test-days.

Trial locations and contacts

1 site in 1 country.

Denmark1 site

University of Southern Denmark
Odense, Region Syddanmark, 5000

Other trials in Denmark

About this study

Official title: INFLAMMATION AND DRUG METABOLISM - Does the Effect of Drugs Decrease When Patients With Type 2 Diabetes Initiate Antidiabetic Treatment?

Type 2 diabetes is a major public health concern. It is widely established that type 2 diabetes in linked to activated innate immunity and increased levels of C-reactive protein and interleukin-6 (IL-6) in plasma. Studies in humans and in liver cells has shown that IL-6 downregulates important drug metabolizing enzymes in the liver (cytochrome P450 (CYP) enzymes). More than half of the most prescribed drugs are eliminated by biotransformation of these enzymes.

The investigators have previously shown that initiating glucose-lowering treatment (e.g. metformin, sulphonylureas and insulin) leads to decreased therapeutic efficacy of the blood-thinning vitamin-K antagonist warfarin. Due to the non-specific effect of glucose lowering drugs, the investigators hypothesize that this is caused by the glucose-lowering effect rather than drug-drug interactions caused by the individual drugs.

Based on the proposal that reversal of increased plasma glucose affects drug metabolism, the investigators will perform a clinical pharmacokinetic trial. The purpose of the study is to elucidate whether initiation of glucose-lowering treatment causes altered drug metabolism among patients with type 2 diabetes. The study will include newly diagnosed and untreated type 2 diabetes patients who will ingest a 6-drug cocktail consisting of probes for specific CYP enzymes. Plasma and urine will be drawn over 6 hours to determine concentrations of the drugs and their metabolites. Patients will then initiate metformin treatment and to assess both short- and long-term impact of glucose-lowering, the same 6-drug cocktail will be ingested, and concentrations measured, after three weeks and three months. To help understand the mechanism and the putative involvement of inflammation, markers of inflammation such as cytokines, transcription factors, etc. will also be assesses.

Conditions: Diabetes Mellitus, Type 2
Being tested: Metformin, Caffeine, Efavirenz, Losartan, Omeprazol
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

MetforminDrug
Also called Glucose lowering treatment
500 mg tablet
CaffeineDrug
As part of a 6-drug cocktail caffeine 100 mg tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP1A2 activity.
EfavirenzDrug
As part of a 6-drug cocktail efavirenz 50 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2B6 activity.
LosartanDrug
As part of a 6-drug cocktail losartan 12.5 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C9 activity.
OmeprazolDrug
As part of a 6-drug cocktail Omeprazol 10 mg enteric-coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C19 activity.
MetoprololDrug
As part of a 6-drug cocktail metoprolol 12.5 mg release tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2D6 activity.
MidazolamDrug
As part of a 6-drug cocktail midazolam 2 mg oral solution will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP3A4 activity.

Study groups in NCT04504045
Study group	Role	What they receive
Metformin	Experimental	Patients will receive metformin 1000-2000 mg daily for 12 weeks. Receives: Drug: Metformin; Drug: Caffeine; Drug: Efavirenz; Drug: Losartan; Drug: Omeprazol; Drug: Metoprolol; Drug: Midazolam

What is being measured

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

Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 3.
Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 3 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4).
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 12.
Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 12 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4).
Measured: Baseline and Week 12.

Secondary outcomes (32)

Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 3.
Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine.
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 12.
Change in activity of the drug metabolizing enzymes CYP1A2 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug caffeine.
Measured: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 3.
Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz.
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 12.
Change in activity of the drug metabolizing enzymes CYP2B6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Efavirenz.
Measured: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 3.
Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan.
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 12.
Change in activity of the drug metabolizing enzymes CYP2C9 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Losartan.
Measured: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 3.
Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole.
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 12.
Change in activity of the drug metabolizing enzymes CYP2C19 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Omeprazole.
Measured: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 3.
Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 3 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol.
Measured: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 12.
Change in activity of the drug metabolizing enzymes CYP2D6 following treatment with the glucose lowering drug metformin after 12 weeks. The change in activity is based on the metabolic rate for the probe drug Metoprolol.
Measured: Baseline and Week 12.
Change from Baseline in HbA1c at Week 3.
Change in the regulation of blood glucose over time assessed by HbA1c
Measured: Baseline and Week 3.
Change from Baseline in HbA1c at Week 12.
Change in the regulation of blood glucose over time assessed by HbA1c
Measured: Baseline and Week 12.
Change from Baseline in insulin resistance at Week 3.
An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance.
Measured: Baseline and Week 3.
Change from Baseline in insulin resistance at Week 12.
An oral glucose tolerance test will be performed and glucose, insulin and c-peptide will be measured and combined by the Homeostatic Model Assessment (HOMA) to report insulin resistance.
Measured: Baseline and Week 12.
Change from Baseline in Interleukin-1-B at Week 3.
Change in patients inflammatory status assessed by measurement of Interleukin-1-B.
Measured: Baseline and Week 3.
Change from Baseline in Interleukin-1-B at Week 12.
Change in patients inflammatory status assessed by measurement of Interleukin-1-B.
Measured: Baseline and Week 12.
Change from Baseline in Interleukin-2 at Week 3.
Change in patients inflammatory status assessed by measurement of Interleukin-2.
Measured: Baseline and Week 3.
Change from Baseline in Interleukin-2 at Week 12.
Change in patients inflammatory status assessed by measurement of Interleukin-2.
Measured: Baseline and Week 12.
Change from Baseline in Interleukin-6 at Week 3.
Change in patients inflammatory status assessed by measurement of Interleukin-6.
Measured: Baseline and Week 3.
Change from Baseline in Interleukin-6 at Week 12.
Change in patients inflammatory status assessed by measurement of Interleukin-6.
Measured: Baseline and Week 12.
Change from Baseline in Interleukin-10 at Week 3.
Change in patients inflammatory status assessed by measurement of Interleukin-10.
Measured: Baseline and Week 3.
Change from Baseline in Interleukin-10 at Week 12.
Change in patients inflammatory status assessed by measurement of Interleukin-10.
Measured: Baseline and Week 12.
Change from Baseline in Interferon-a at Week 3.
Change in patients inflammatory status assessed by measurement of Interferon-a.
Measured: Baseline and Week 3.
Change from Baseline in Interferon-a at Week 12.
Change in patients inflammatory status assessed by measurement of Interferon-a.
Measured: Baseline and Week 12.
Change from Baseline in Interferon-B at Week 3.
Change in patients inflammatory status assessed by measurement of Interferon-B.
Measured: Baseline and Week 3.
Change from Baseline in Interferon-B at Week 12.
Change in patients inflammatory status assessed by measurement of Interferon-B.
Measured: Baseline and Week 12.
Change from Baseline in Interferon-y at Week 3.
Change in patients inflammatory status assessed by measurement of Interferon-y.
Measured: Baseline and Week 3.
Change from Baseline in Interferon-y at Week 12.
Change in patients inflammatory status assessed by measurement of Interferon-y.
Measured: Baseline and Week 12.
Change from Baseline in Tumor Necrosis Factor-a at Week 3.
Change in patients inflammatory status assessed by measurement of Tumor Necrosis Factor-a.
Measured: Baseline and Week 3.
Change from Baseline in Tumor Necrosis Factor-a at Week 12.
Change in patients inflammatory status assessed by measurement of Tumor Necrosis Factor-a.
Measured: Baseline and Week 12.
Change from Baseline in High Sensitivity C-Reactive Protein at Week 3.
Change in patients inflammatory status assessed by measurement of High Sensitivity C-Reactive Protein.
Measured: Baseline and Week 3.
Change from Baseline in High Sensitivity C-Reactive Protein at Week 12.
Change in patients inflammatory status assessed by measurement of High Sensitivity C-Reactive Protein.
Measured: Baseline and Week 12.

Timeline

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

1 Sep 202010 May 2022

First posted7 Aug 2020
Study start1 Sep 2020
Primary completion10 May 2022
Study completion10 May 2022

Why it stopped: Slow recruitment due to COVID-19, the study was stopped when recruited numbers fulfilled the pre-defined lower sample size.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by University of Southern DenmarkThe sponsor's other registered studies.
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 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04504045
Sponsor's protocol ID: AKF-395
Other IDs: 2020-000162-42
Status last verified: Jun 2022
First submitted: 29 Jul 2020
Last updated: 16 Jun 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data cannot be shared due to general data protection regulation (GDPR).

Publications

Stage TB, Pottegard A, Henriksen DP, Christensen MM, Hojlund K, Brosen K, Damkier P. Initiation of glucose-lowering treatment decreases international normalized ratio levels among users of vitamin K antagonists: a self-controlled register study. J Thromb Haemost. 2016 Jan;14(1):129-33. doi: 10.1111/jth.13187. Epub 2015 Dec 29.
PubMed 26559049
Dunvald AD, Nielsen F, Olsen DA, Ernst MT, Donnelly L, Soto-Pedre E, Kristiansen MR, Nielsen JS, Persson F, Hojlund K, Madsen JS, Sondergaard J, Pearson E, Pottegard A, Stage TB. Initiation of glucose-lowering drugs reduces the anticoagulant effect of warfarin-But not through altered drug metabolism in patients with type 2 diabetes. Br J Clin Pharmacol. 2023 Aug;89(8):2529-2541. doi: 10.1111/bcp.15725. Epub 2023 Apr 14.
PubMed 36967527

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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: INFLAMMATION AND DRUG METABOLISM - Does the Effect of Drugs Decrease When Patients With Type 2 Diabetes Initiate Antidiabetic Treatment?
ClinicalTrials.gov ID: NCT04504045
Acronym / sponsor ID: AKF-395
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment due to COVID-19, the study was stopped when recruited numbers fulfilled the pre-defined lower sample size.
Enrolment: 10 participants (actual)
Lead sponsor: University of Southern DenmarkUniversity, hospital or other
Study start: 1 Sep 2020 (actual)
Primary completion: 10 May 2022 (actual)
Study completion: 10 May 2022 (actual)
First posted: 7 Aug 2020 (actual)
Results: Not posted in the source record

Clinical summary

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

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Metformin	Experimental	Drug: Metformin, Drug: Caffeine, Drug: Efavirenz, Drug: Losartan, Drug: Omeprazol, Drug: Metoprolol, Drug: MidazolamPatients will receive metformin 1000-2000 mg daily for 12 weeks.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Type 2 diabetes, not treated metformin.
Hemoglobin 1Ac (HbA1c): ≥48 mmol/mol
Age: 18-75 years
Body Mass Index (BMI) ≤ 40 kg/m2
Estimated Glomerular Filtration Rate (eGFR) > 60 mL/min

Key exclusion criteria (8 listed)

Acute or chronic infection or inflammation
Active cancer
Glutamic acid decarboxylase (GAD)-antibodies
Known hypersensitivity to one or several of the drugs
Intake of medications which can influence the safety of the patient or the results of the study

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
MetforminAlso: Glucose lowering treatment500 mg tablet	Drug	Metformin
CaffeineAs part of a 6-drug cocktail caffeine 100 mg tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP1A2 activity.	Drug	Metformin
EfavirenzAs part of a 6-drug cocktail efavirenz 50 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2B6 activity.	Drug	Metformin
LosartanAs part of a 6-drug cocktail losartan 12.5 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C9 activity.	Drug	Metformin
OmeprazolAs part of a 6-drug cocktail Omeprazol 10 mg enteric-coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C19 activity.	Drug	Metformin
MetoprololAs part of a 6-drug cocktail metoprolol 12.5 mg release tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2D6 activity.	Drug	Metformin
MidazolamAs part of a 6-drug cocktail midazolam 2 mg oral solution will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP3A4 activity.	Drug	Metformin

Primary outcome

Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 3.
Time frame: Baseline and Week 3.
Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 3 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4).
Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 12.
Time frame: Baseline and Week 12.
Change in activity of the drug metabolizing enzyme CYP3A4 following treatment with the glucose lowering drug metformin in 12 weeks. Assessment of the change is based on a change in the metabolic rate, which is the ratio between the concentration of midazolam and its primary metabolite is plasma (Probe drug for CYP3A4).

32 secondary outcomes

Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Caffeine (CYP1A2) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Efavirenz (CYP2B6) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Losartan (CYP2C9) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Omeprazole (CYP2C19) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Metabolic Rate of Metoprolol (CYP2D6) at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in HbA1c at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in HbA1c at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in insulin resistance at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in insulin resistance at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interleukin-1-B at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interleukin-1-B at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interleukin-2 at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interleukin-2 at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interleukin-6 at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interleukin-6 at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interleukin-10 at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interleukin-10 at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interferon-a at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interferon-a at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interferon-B at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interferon-B at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Interferon-y at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Interferon-y at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in Tumor Necrosis Factor-a at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in Tumor Necrosis Factor-a at Week 12.
Time frame: Baseline and Week 12.
Change from Baseline in High Sensitivity C-Reactive Protein at Week 3.
Time frame: Baseline and Week 3.
Change from Baseline in High Sensitivity C-Reactive Protein at Week 12.
Time frame: Baseline and Week 12.

Results and safety

The study was stopped early (reason given: Slow recruitment due to COVID-19, the study was stopped when recruited numbers fulfilled the pre-defined lower sample size.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
Background: PubMed 26559049Stage TB, Pottegard A, Henriksen DP, Christensen MM, Hojlund K, Brosen K, Damkier P. Initiation of glucose-lowering treatment decreases international normalized ratio levels among users of vitamin K antagonists: a self-controlled register study. J Thromb Haemost. 2016 Jan;14(1):129-33. doi: 10.1111/jth.13187. Epub 2015 Dec 29.
Derived from this study: PubMed 36967527Dunvald AD, Nielsen F, Olsen DA, Ernst MT, Donnelly L, Soto-Pedre E, Kristiansen MR, Nielsen JS, Persson F, Hojlund K, Madsen JS, Sondergaard J, Pearson E, Pottegard A, Stage TB. Initiation of glucose-lowering drugs reduces the anticoagulant effect of warfarin-But not through altered drug metabolism in patients with type 2 diabetes. Br J Clin Pharmacol. 2023 Aug;89(8):2529-2541. doi: 10.1111/bcp.15725. Epub 2023 Apr 14.
Individual participant dataSharing planned: No. Individual participant data cannot be shared due to general data protection regulation (GDPR).

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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.

Ann-Cathrine Dunvald, MD principal investigator

University of Southern Denmark

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Metformin, Caffeine and Efavirenz in people with Diabetes Mellitus, Type 2, run by University of Southern Denmark at 1 site in Denmark.

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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 16 Jun 2022. 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 Denmark. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

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?

Change from Baseline in Metabolic Rate of Midazolam (CYP3A4) at Week 3. (time frame: Baseline and Week 3.). The study lists 2 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 NCT04504045, which also lists 2 linked publications.

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 16 Jun 2022.