Injections of Glutamic Acid Decarboxylase (GAD) for LADA Type of Diabetes (GADinLADA)
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ClinicalTrials.gov Identifier: NCT04262479 |
Recruitment Status :
Active, not recruiting
First Posted : February 10, 2020
Last Update Posted : October 19, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Latent Autoimmune Diabetes in Adults | Drug: recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel Drug: Vitamin D | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study on Safety, Feasibility and Insulin-promotion by Intra-inguinal Lymph Node Injections of Glutamic Acid Decarboxylase (GAD) in Patients With LADA Type of Diabetes |
Actual Study Start Date : | March 2, 2020 |
Estimated Primary Completion Date : | May 2022 |
Estimated Study Completion Date : | May 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: GAD-vaccination with vitamin D suppletion
Each study participant will receive 3 injections of 4 µg GAD-alum (Diamyd). The first, second and third injection will be one month apart. Vitamin D (Divisun 2000 IE) will be given from one month before the first injection of GAD-alum until one month after the third injection (120 days in total). |
Drug: recombinant human glutamic acid dehydrogenase (rhGAD65), formulated in aluminium hydrogel
3 intra-inguinal injections (into the lymph nodes) of GAD-alum one month apart. Supplier Diamyd Medical AB in Stockholm, Sweden
Other Name: GAD-alum (Diamyd(R)) Drug: Vitamin D 1 tablet/day, total daily dose of 2000 IE given per os from day -30 through day 90. Supplier Meda, Solna, Sweden
Other Name: Divisun 2000 IE |
- injection site skin reactions [ Time Frame: 1 hour ]skin reactions 1 hour post injection vs. before injection
- Occurrence of adverse events (AEs) [ Time Frame: summarized at 5 months ]continuously monitored and registered
- Occurrence of adverse events (AEs) [ Time Frame: summarized at 12 months ]continuously monitored and registered
- GAD65A titer in serum [ Time Frame: at 5 months ]concentration in serum after the first injection vs baseline
- GAD65A titer in serum [ Time Frame: at 12 months ]concentration in serum after the first injection vs baseline
- Insulin secretion [ Time Frame: 5 months after first injection ]measured by glucagon- and MMTT stimulated C-peptide
- insulin secretion [ Time Frame: 12 months after first injection ]measured by glucagon- and MMTT stimulated C-peptide
- Change in HbA1c [ Time Frame: from baseline to 5 and 12 months after the first injection ]
- Change in fasting glucose [ Time Frame: from baseline to 5 and 12 months after the first injection ]
- Change in Fasting C-peptide [ Time Frame: between baseline and 5 and 12 months after the first injection ]
- Change in maximum C-peptide during Mixed Meal Tolerance Test (MMTT) [ Time Frame: between baseline and 5 and 12 months after the first injection ]

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Ages Eligible for Study: | 30 Years to 70 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent by the patient.
- Diagnosis of LADA and diabetes debut within the last 18 months before inclusion. LADA should be defined by the criteria of age ≥30 years at the onset of diabetes, anti-GAD positivity and no clinical need for permanent insulin treatment during the first 3 months after the diagnosis of diabetes.
- Fasting C-peptid levels ≥ 0.3 nmol/l
- High GADA titers (>190 U/ml)
- Patients must be insulin independent at baseline by clinical judgement and C-peptide criteria
- Antidiabetic medication in the form of metformin is acceptable for inclusion as well as medications not mentioned under exclusion criteria
- Females must agree to avoid pregnancy, and must 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 GAD-alum. 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:
- Current or previous treatment with immunosuppressant therapy (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)
- Systemic treatment with glucocorticoids
- Treatment with any vaccine, including influenza vaccine, within 1 month prior to planned first study drug dose or planned treatment with any vaccine up to 1 month after the last injection with study drug
- Antidiabetic medication (metformin excepted)
- Significantly abnormal hematology results at screening (i.e. anemia with hemoglobin < 12 g/L).
- 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 in the past.
- Renal disease (as defined by serum creatinine >150 µmol/l)
- Serious cardiovascular events (myocardial infarction, stroke) within the last year preceding recruitment.
- Participation in other clinical trials with a new chemical entity within the previous 3 months
- A history of alcohol or drug abuse
- Known HIV or hepatitis
- 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
- Other serious chronic disease as judged by investigator.
- Females who are lactating, are pregnant or intend to become pregnant.
- Inability or unwillingness to comply with the provisions of this protocol
- Deemed by the investigator not being able to follow instructions and/or follow the study protocol
- Treatment any other supplementation of with vitamin D, marketed or not, or unwilling to abstain from such medication during the trial 120 days daily intake of Divisun (non-investigational medicinal product)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04262479
Norway | |
Department of Endocrinology, St Olavs Hospital | |
Trondheim, Norway | |
Sweden | |
Akademiskt Specialistcentrum, Centrum for Diabetes, and Karolinska Institute | |
Stockholm, Sweden |
Study Director: | Anne Hildur Henriksen, MD PhD | St Olavs Hospital, Medisinsk Klinikk | |
Study Director: | Torstein Baade Rø, MD | Norwegian University of Science and Technology, IKOM |
Responsible Party: | Norwegian University of Science and Technology |
ClinicalTrials.gov Identifier: | NCT04262479 |
Other Study ID Numbers: |
GADinLADA 2019-002692-34 ( EudraCT Number ) |
First Posted: | February 10, 2020 Key Record Dates |
Last Update Posted: | October 19, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | There is not a plan to make IPD available. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Glutamic Acid Decarboxylase Alum Compounds Injections Inguinal Canal |
Diamyd rhGAD65 Vitamin D |
Diabetes Mellitus Diabetes Mellitus, Type 1 Latent Autoimmune Diabetes in Adults Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases |
Immune System Diseases Vitamin D Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents |