An early phase study in patients with Type 2 Diabetes to assess the effect on glucose homeostasis of two dose levels of AZD9567, compared to Prednisolone
- Conditions
- Type 2 DiabetesMedDRA version: 21.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2020-000931-35-DE
- Lead Sponsor
- AstraZeneca AB, 151 85 Södertälje, Sweden
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
1. Participant must be aged 18 to 75 years of age inclusive, at the time of Visit 1.
2. Participants with diagnosis of T2DM for 6 months prior to screening: HbA1c in the diabetes range or fasting blood glucose 126 220 mg/dL.
3. On stable metformin therapy for at least 4 weeks, where no significant dose change (increase or decrease = 500 mg/day) has occurred prior to screening and HbA1c 6% – 9.5%, or on dual therapy with metformin in combination with SGLT2i or DPP4i and HbA1c 6% – 8%. Participants on dual therapy will require 2 weeks wash-out of SGLT2i or DPP4i.
4. Venous access suitable for multiple cannulations.
5. Sex: males and females.
Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
(a) Male participants: All male participants must be willing to avoid fathering a child by either true abstinence or use (together with their female partner/spouse) a highly effective contraception form of birth control in combination with a barrier method, starting from the time of study intervention administration until 3 months after the Final/ET visit. Acceptable methods of preventing pregnancy are provided below.
6. Female participants must be not lactating and not of childbearing potential, defined as those who are surgically sterile (ie, bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy) or are postmenopausal (defined as at least 1 year since last menses and having an elevated [> 40 mIU/mL] FSH laboratory value at screening).
If sexually active, nonsterilized males who have a female partner of childbearing potential must practice two effective contraceptive measures from screening through at least 28 days after the last dose of IMP has been administered. Note: Male condom plus spermicide is only considered an effective contraceptive measure when used together with another method based on following list (none of the listed methods are intended to be used alone). Highly Effective Methods of Contraception include:
(a) Tubal occlusion
(b) Copper T intrauterine device
(c) Levonorgestrel-releasing intrauterine system (eg, Mirena®)
(d) Medroxyprogesterone injections (eg, Depo-Provera®)
(e) Etonogestrel implants (eg, Implanon®, Norplan®)
(f) Combined pills
(g) Norelgestromin/ethinyl estradiol transdermal system (eg, Ortho Evra®)
(h) Intravaginal device (eg, NuvaRing®)
(i) Desogestrel (Cerazette®).
7. Capable of giving signed informed consent.
8. Provision of informed consent prior to any study specific procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 34
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
1. History or presence of type 1 diabetes.
2. History of severe hypoglycaemia or hypoglycaemia unawareness within the last 6 months.
3. History or presence of diabetic foot ulcers.
4. Participants with advanced diabetic complications (eg, symptomatic nephropathy, gastroparesis, proliferative retinopathy, significant atherosclerotic disease, congestive, heart failure etc).
5. History of clinically significant lactic acidosis or ketoacidosis following diagnosis with T2DM.
6. History of, or known significant infection or positivity at Visit 1, including hepatitis A, B, or C, HIV, tuberculosis (ie, positive result for interferon-? release assay, QuantiFERON® TB Gold), that may put the participant at risk during participation in the study.
7. History and / or presence of COVID-19:
(a) Participants who have had a severe course of COVID-19 (ie, hospitalisation, extracorporeal membrane oxygenation [ECMO], mechanically ventilated)
(b) Participants with clinical signs and symptoms consistent with COVID-19, eg, fever, dry cough, dyspnoea, sore throat, fatigue, or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission to the CRU
(c) Participants with confirmed COVID-19 infection by PCR test before randomisation.
8. Donation of blood (= 450 mL) within 3 months or donation of plasma within 14 days before Visit 1.
9. History of or current alcohol or drug abuse (including marijuana), as judged by the investigator.
10. Previous psychiatric disorders, including but not limited to:
(a) Participants have been committed to an institution by way of official or judicial order
(b) Any active psychiatric illness associated with unstable weight control or which would result in inability to comply with study requirements
(c) History of severe affective disorder including major depressive or maniac-depressive illness
(d) History of previous steroid psychosis.
11. Any latent, acute, or chronic infections or at risk of infection, or history of skin abscesses within 90 days prior to the first administration of IMP at the discretion of the investigator.
12. History of adrenal insufficiency.
13. History or current inflammatory disorder.
14. Any other condition that, in the opinion of the investigator, would interfere with evaluations of the IMP or interpretation of participant safety or study results, including, but not limited to:
(a) History of previous gastric/duodenal ulcers or surgery affecting the upper GI tract likely to affect the interpretation of safety and tolerability data
(b) History of cholelithiasis leading to episodes of acute cholecystitis not treated by cholecystectomy, or known biliary disease
(c) History or presence of dyspepsia or oral intolerance to steroids
(d) History of cancer, with the exception of non-melanoma skin cancer which is considered cured based on investigator assessment
(e) History or presence of any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
15. History of severe allergy/hypersensitivity to AZD9567 or any of the excipients of the product, or ongoing clinically important allergy/hypersensitivity as judged by the investigator.
16. Oral or parenteral steroids 8 weeks prior to randomisation and during the study. Topical and inhaled steroids 4 weeks prior to randomisation are acceptable.
17. Use of any prohibited medication during the study or if the require
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method