Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
30
Countries
1
Sites
1
Insulin resistance
To assess the effect of Pravastatin on insulin sensitivity compared to placebo.
Key facts
- Sponsor
- Aarhus University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 14 Dec 2022 → 23 Jan 2025
- Decision date (initial)
- 2022-09-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- The Health Research Foundation of Central Denmark Region · The Jascha Foundation · The Augustinus Foundation · The Research Foundation of The Danish Renal Association
External identifiers
- EU CT number
- 2022-501068-16-00
- WHO UTN
- U2022-0105-1707
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the effect of Pravastatin on insulin sensitivity compared to placebo.
Secondary objectives 3
- To evaluate the effect of Pravastatin on insulin secretion, hormone levels and apllicability of surroate indices for insulin sensitivity
- Assess the effect of Pravastatin on insulin signalling pathways on the level of gene and protein expression
- Assess changes in faecal microbiota composition following treatment with Pravastatin
Conditions and MedDRA coding
Insulin resistance
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- STUDY 1: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Renal transplantation > 6 months prior to inclusion; 4) Combination immunosuppressive treatment with mycophenolate, tacrolimus, and prednisolone; 5) eGFR > 29 ml/min; 6) Written, informed consent prior to study inclusion
- STUDY 2: 1) Age 40-70 years; 2) BMI 20-30 kg/m2; 3) Chronic kidney disease stage 3 i.e., eGFR > 29 ml/min and < 60 ml/min; 4) Written, informed consent prior to study inclusion
Exclusion criteria 2
- STUDY 1: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Regular treatment with doses of prednisolone > 5 mg daily; 4) Treatment with prednisolone > 15 mg/day for > 5 days, for any reason within 3 months prior to inclusion; 5) Average change in eGFR of > 5 mL/min estimated over 3 months prior to screening; 6) Blood tacrolimus level continuously outside target range; 7) Known allergy towards study medication; 8) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 9) Prior, severe reaction to or severe side effect from any type of statin; 10) Active or chronic liver disease with serum concentration of ALAT > thrice the upper limit of normal (ULN), or spontaneous INR > 1,5; 11) Pre-existing myositis; 12) Plasma CK concentration > 4 times the ULN; 13) Hereditary galactose intolerance or known glucose/galactose malabsorption; 14) Any other organ transplantation prior to or during the trial; 15) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 16) Inability to understand the spoken and written information given and/or inability to give informed consent; 17) Being under legal guardianship
- STUDY 2: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Treatment with antidiabetic medication, other than SGLT2-inhibitors for cardio- or renal protective purposes only, and GLP-1 analogs for weight reduction purposes only; 4) Treatment with glucocorticoids or other immunosuppressive medication of any kind; 5) Known allergy towards study medication; 6) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 7) Prior, severe reaction to or severe side effect from any type of statin; 8) Active or chronic liver disease with serum concentration of ALAT > thrice the ULN, or spontaneous INR > 1,5; 9) Pre-existing myositis from any cause; 10) Plasma CK concentration > 4 times the ULN; 11) Hereditary galactose intolerance or known glucose/galactose malabsorption; 12) Any organ transplantation prior to or during the trial; 13) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 14) Inability to understand the spoken and written information given and/or inability to give informed consent; 15) Being under legal guardianship
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Insulin sensitivity assessed by hyperinsulinemic euglycemic glucose clamp
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Pravastatin Sandoz 40 mg tabletter
PRD1668255 · Product
- Active substance
- Pravastatin Sodium
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 4480 mg milligram(s)
- Max treatment duration
- 16 Week(s)
- Authorisation status
- Authorised
- ATC code
- C10AA03 — PRAVASTATIN
- Marketing authorisation
- 04-2432
- MA holder
- SANDOZ A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Encapsulation with the purpose of blinding
Placebo 1
Name: Placebotablet 8 mm. Content supplied in the document Placebo Cataloging Form RAP 8 mm.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Auxiliary 3
SCP971236 · ATC
- Active substance
- Potassium Chloride
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 Mmol millimole(s)
- Max total dose
- 50 Mmol millimole(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05XA01 — POTASSIUM CHLORIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1739723 · ATC
- Active substance
- Insulin Human (Rdna)
- Substance synonyms
- INSULIN, HUMAN BIOSYNTHETIC, INSULIN HUMAN, RDNA, INSULIN HUMAN BIOSYNTHETIC, INSULIN HUMAN RECOMBINANT, INSULIN HUMAN (GENETICAL RECOMBINATION), INSULIN HUMAN,BIOSYNTHETIC
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 IU international unit(s)
- Max total dose
- 50 IU international unit(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- A10AB01 — INSULIN (HUMAN)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP4869918 · ATC
- Active substance
- Anhydrous Glucose Bp
- Substance synonyms
- Glucose anhydrous BP
- Route of administration
- INTRAVENOUS
- Max daily dose
- 275 g gram(s)
- Max total dose
- 550 g gram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BA03 — CARBOHYDRATES
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Aarhus University Hospital
- Sponsor organisation
- Aarhus University Hospital
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Mai-Britt Skadborg
Public contact point
- Organisation
- Aarhus University Hospital
- Contact name
- Mai-Britt Skadborg
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus University ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2022-12-14 | 2025-01-23 | 2023-01-16 | 2024-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Final report on clinical trial results INSTA SUM-115308
|
2026-01-22T21:39:27 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lægmandsresumé af klinisk forsøg INSTA | 2026-01-22T21:39:34 | Submitted | Laypersons Summary of Results |
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Dansk lgmandsresume af afsluttende rapport for klinisk forsg INSTA | 1 |
| Protocol (for publication) | INSTA Protocol REDACTED | 5 |
| Summary of Product Characteristics (SmPC) (for publication) | SmPC Pravastatin Sandoz INSTA | 1 |
| Summary of results (for publication) | Final report on clinical trial results INSTA with annex | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-07-05 | Denmark | Acceptable 2022-09-23
|
2022-09-26 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-10-31 | Denmark | Acceptable 2022-12-16
|
2022-12-16 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-05-22 | Denmark | Acceptable 2023-06-22
|
2023-06-30 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-08-28 | Denmark | Acceptable 2023-06-22
|
2024-08-28 |