Diabetes InsipidusPhase 1NCT02460354
Metformin and Congenital Nephrogenic Diabetes Insipidus
A Phase 1 study testing Metformin in people with Diabetes Insipidus, run by Emory University at 3 sites in United States.
Trial summary
The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Diabetes Insipidus
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 3 sitesUnited States
- Study dates
- Sep 2015to Jun 2017
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with a documented mutation in the vasopressin type 2 receptor (V2R)
- Willing to provide consent and/or assent as appropriate
- Capable of providing urine samples as dictated by the protocol
Who cannot join
- Urinary incontinence
- Subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than Nephrogenic Diabetes Insipidus (NDI)
- Subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (GFR) <80 ml/min/1.73 m^2)
- Subjects with acquired NDI
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Childen's Healthcare of Atlanta
Atlanta, Georgia, 30322
Emory University Hospital - Atlanta Clinical and Translational Science Institute (ACTSI)
Atlanta, Georgia, 30322
Emory University Hospital
Atlanta, Georgia, 30322
About this study
Official title: Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).
Read the detailed description
Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.
- Conditions
- Diabetes Insipidus
- Being tested
- Metformin
- Keywords
- Congenital nephrogenic diabetes insipidus
- Medical subject headings
- Diabetes Insipidus, Diabetes Insipidus, Nephrogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glumetza, Fortamet, Glucophage, Riomet
Metformin 500 mg pill dispensed once orally
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Experimental | Subjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally Receives: Drug: Metformin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mean urine osmolality
Urine osmolality is a measure of urine concentration. Urine osmolality will be measured using a Wescor vapor pressure osmometer. A normal range for urine osmolality is approximately 500-850 mOsm/kg water. Change is the difference in average osmolality from baseline to 7 hours.
Measured: Baseline, 7 hours
Secondary outcomes (1)
Change in mean urine volume
Urine volume is a measure of fluid balance. Change from baseline in average volume of urine collected from baseline to 7 hours.
Measured: Baseline, 7 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startSep 2015
- Primary completionJun 2017
- Study completionJun 2017
Why it stopped: Lack of effect in initial subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes InsipidusStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Larry Greenbaum, MD, PhD, Emory University
- Investigators
- Larry Greenbaum, MD, PhD, Principal investigator, Emory UniversityTitilayo Ilori, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02460354
- Sponsor's protocol ID
- IRB00077633
- Status last verified
- Jul 2018
- First submitted
- 29 May 2015
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Metformin to Treat Patients With Congenital Nephrogenic Diabetes Insipidus (NDI)
- ClinicalTrials.gov ID
- NCT02460354
- Acronym / sponsor ID
- IRB00077633
- Conditions
- Diabetes Insipidus
- Keywords
- Congenital nephrogenic diabetes insipidus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of effect in initial subjects
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 2 Jun 2015 (estimated)
- 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.
The purpose of this study is to determine whether metformin can increase urine concentration (osmolality) and decrease the amount of urine in patients with congenital nephrogenic diabetes insipidus (NDI).
Detailed description
Nephrogenic diabetes insipidus (NDI) is a genetic disease. Patients with this disease make large amounts of urine because their kidneys don't hold on to water. The large amount of urine means that patients need to urinate very frequently. They are also at increased risk for dehydration if they don't drink enough. The large amount of urine can sometimes damage their bladders and kidneys. There are some medicines that may help these patients urinate less, but they are not very effective. There is evidence in animal studies that a medication called metformin may help patients with NDI urinate less.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Metformin | Experimental | Drug: MetforminSubjects with congenital nephrogenic diabetes insipidus (NDI) will receive one metformin 500 mg pill orally |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males with a documented mutation in the vasopressin type 2 receptor (V2R)
- Willing to provide consent and/or assent as appropriate
- Capable of providing urine samples as dictated by the protocol
Key exclusion criteria (4 listed)
- Urinary incontinence
- Subjects who have heart disease, liver disease, diabetes, cancer, or other significant disease other than Nephrogenic Diabetes Insipidus (NDI)
- Subjects with significant renal dysfunction (defined as a calculated glomerular filtration rate (GFR) <80 ml/min/1.73 m^2)
- Subjects with acquired NDI
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: Glumetza, Fortamet, Glucophage, RiometMetformin 500 mg pill dispensed once orally | Drug | Metformin |
Primary outcome
Change in mean urine osmolality
Time frame: Baseline, 7 hours
Urine osmolality is a measure of urine concentration. Urine osmolality will be measured using a Wescor vapor pressure osmometer. A normal range for urine osmolality is approximately 500-850 mOsm/kg water. Change is the difference in average osmolality from baseline to 7 hours.
1 secondary outcome
Change in mean urine volume
Time frame: Baseline, 7 hours
Results and safety
The study was stopped early (reason given: Lack of effect in initial subjects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
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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.
Larry Greenbaum, MD, PhD principal investigator
Emory University
Titilayo Ilori, MD principal investigator
Emory University
3 sites 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 in people with Diabetes Insipidus, run by Emory University at 3 sites in United States.
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 3 inclusion and 4 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 17 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
The study was stopped early (reason given: Lack of effect in initial subjects). Results are not available in the source record.
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 in mean urine osmolality (time frame: Baseline, 7 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.