Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes

D

Diamyd Medical

Status and phase

Completed
Phase 2

Conditions

Diabetes Mellitus, Type 1
Physiological Effects of Drugs
Diabetes Mellitus
Immune System Diseases
Juvenile Diabetes
Endocrine System Diseases
Autoimmune Diseases
Glucose Metabolism Disorders
Autoimmune Diabetes
Metabolic Disease
Vitamin D
Insulin Dependent Diabetes

Treatments

Dietary Supplement: Vitamin D
Biological: Placebo for Diamyd
Biological: Diamyd
Dietary Supplement: Placebo for Vitamin D

Study type

Interventional

Funder types

Industry

Identifiers

NCT03345004
DIAGNODE-2 (D/P2/17/6)
2017-001861-25 (EudraCT Number)

Details and patient eligibility

About

The objective of DIAGNODE-2 is to evaluate the efficacy of Diamyd compared to Placebo, upon administration directly into a lymph node in combination with an oral vitamin D/Placebo regimen, in terms of preserving endogenous insulin secretion as measured by C-peptide.

Full description

The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial. Eligible patients will receive injections of Diamyd/placebo into an inguinal lymph gland at three occasions, with one month intervals in combination with an oral vitamin D/placebo regimen (starting 1 month ahead of injections) during 4 months. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period. The patients will be followed in a blinded manner for a total of 15 months. All patients that have not performed the 15 months visit when the updated protocol is implemented, will be asked to participate in the Extension Study Period which includes an additional visit at month 24.

Enrollment

109 patients

Sex

All

Ages

12 to 24 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
  • Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening
  • Age: ≥12 and <25 years old
  • Fasting C-peptide ≥0.12 nmol/L (0.36 ng/ml) on at least one occasion (maximum 2 tests on different days within a period of 2 weeks)
  • Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml

Females must agree to avoid pregnancy and have a negative urine pregnancy test. Patients of childbearing potential must agree to use adequate contraception, until one (1) year after the last administration of Diamyd. Adequate contraception is as follows:

For females of childbearing potential:

  • oral (except low-dose gestagen (lynestrenol and norestisteron)), injectable, or implanted hormonal contraceptives
  • combined (estrogen and progestogen containing)
  • oral, intravaginal or transdermal progesterone hormonal contraception associated with inhibition of ovulation
  • intrauterine device
  • intrauterine hormone-releasing system (for example, progestin-releasing coil)
  • bilateral tubal occlusion
  • vasectomized male (with appropriate post vasectomy documentation of the absence of sperm in the ejaculate)
  • male partner using condom
  • abstinence from heterosexual intercourse

For males of childbearing potential:

  • condom (male)
  • abstinence from heterosexual intercourse

Exclusion criteria

  • Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
  • Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
  • Treatment with any oral or injected anti-diabetic medications other than insulin
  • A history of anemia or significantly abnormal hematology results at screening
  • A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
  • Clinically significant history of acute reaction to vaccines or other drugs in the past
  • Treatment with any vaccine, including influenza vaccine, within 4 months prior to planned first study drug dose or planned treatment with any vaccine up to 4 months after the last injection with study drug.
  • Participation in other clinical trials with a new chemical entity within the previous 3 months
  • Inability or unwillingness to comply with the provisions of this protocol
  • A history of alcohol or drug abuse
  • A significant illness other than diabetes within 2 weeks prior to first dosing
  • Known HIV or hepatitis
  • Females who are lactating or pregnant (the possibility of pregnancy must be excluded by urine βHCG on-site within 24 hours prior to the Diamyd/placebo treatment)
  • Presence of associated serious disease or condition, including active skin infections that preclude intralymphatic injection, which in the opinion of the investigator makes the patient non-eligible for the study
  • Deemed by the investigator not being able to follow instructions and/or follow the study protocol

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

109 participants in 2 patient groups, including a placebo group

Active arm
Active Comparator group
Description:
Patients will be assigned to receive i) three (3) intralymphatic injections with Recombinant human Glutamic Acid Decarboxylase adsorbed to Alhydrogel (Diamyd) on Days 30, 60, and 90 and; ii) oral vitamin D 2000 IU/daily for 4 months (from Day 1 through Day 120)
Treatment:
Biological: Diamyd
Dietary Supplement: Vitamin D
Placebo arm
Placebo Comparator group
Description:
Patients will be assigned to receive i) three (3) intralymphatic injections of Placebo for Diamyd on Days 30, 60, and 90 and; ii) oral Placebo for vitamin D once a day for 4 months (from Day 1 through Day 120)
Treatment:
Dietary Supplement: Placebo for Vitamin D
Biological: Placebo for Diamyd

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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