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

Primary Purpose

Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Diamyd
Vitamin D
Placebo for Diamyd
Placebo for Vitamin D
Sponsored by
Diamyd Medical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1 focused on measuring Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes Mellitus, rhGAD65, GAD65, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Vitamins, Micronutrients, Cholecalciferol, Ergocalciferols

Eligibility Criteria

12 Years - 24 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent given by patients and/or patient's parent(s) or legal acceptable representative(s) (guardian(s)) according to national regulations
  2. Type 1 Diabetes (T1D) according to the Amercian Diabetes Association (ADA) classification diagnosed ≤6 months at the time of screening
  3. Age: ≥12 and <25 years old
  4. 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)
  5. Positive for Glutamic Acid Decarboxylase isoform 65 (GAD65A) but < 50 000 IU/ml
  6. 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:

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

For males of childbearing potential:

  1. condom (male)
  2. abstinence from heterosexual intercourse

Exclusion Criteria:

  1. Previous or current treatment with immunosuppressant therapy (although topical or inhaled steroids are accepted)
  2. Continuous treatment with anti-inflammatory drug (sporadic treatment e.g. because of headache or in connection with fever a few days will be accepted)
  3. Treatment with any oral or injected anti-diabetic medications other than insulin
  4. A history of anemia or significantly abnormal hematology results at screening
  5. A history of epilepsy, head trauma or cerebrovascular accident, or clinical features of continuous motor unit activity in proximal muscles
  6. Clinically significant history of acute reaction to vaccines or other drugs in the past
  7. 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.
  8. Participation in other clinical trials with a new chemical entity within the previous 3 months
  9. Inability or unwillingness to comply with the provisions of this protocol
  10. A history of alcohol or drug abuse
  11. A significant illness other than diabetes within 2 weeks prior to first dosing
  12. Known HIV or hepatitis
  13. 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)
  14. 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
  15. Deemed by the investigator not being able to follow instructions and/or follow the study protocol

Sites / Locations

  • Diabetes Centre, Institute of Clinical and Experimental Medicine
  • Department of Paediatrics, University Hospital Motol
  • Diabeter Rotterdam
  • Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces
  • Adult Endocrinology and Diabetology, Hospital vall D' Hebrón
  • Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón
  • Adult Endocrinology and Diabetology, Hospital Ramón y Cajal
  • Adult Endocrinology and Diabetology, Hospital Carlos Haya
  • Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil
  • Adult Endocrinology and Diabetology, Hospital Macarena
  • Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío
  • Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet
  • Barn- och Ungdomskliniken, Universitetssjukhuset
  • Endokrinmedicinska kliniken. Universitetssjukhuset
  • Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus
  • Barn- och ungdomskliniken, Uddevalla Sjukhus
  • Diabetesmottagningen, Uddevalla Sjukhus
  • Barnmottagningen, Norrlands Universitetssjukhus

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active arm

Placebo arm

Arm 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)

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)

Outcomes

Primary Outcome Measures

Change in Stimulated C-peptide During a MMTT
Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.

Secondary Outcome Measures

Change in IDAA1c
Change in insulin-dose-adjusted HbA1c (IDAA1c)
Change in HbA1c
Change in HbA1c (mmol/mol)
Change in Insulin Consumption
Change in daily exogenous insulin consumption (IU)
Change in Glycemic Variability/Fluctuations
Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.
Percentage of Patients With IDAA1c ≤ 9
Percentage of patients with IDAA1c ≤ 9
Stimulated Maximum C-peptide Above 0.2 Nmol/L
Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Stimulated C-peptide Above 0.2 Nmol/L at 90 Min
Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Number of Hypoglycemias
Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)
Number of Patients Having at Least 1 Severe Hypoglycemic Event
Number of patients having at least 1 severe hypoglycemic event (counts)
Change in Maximum C-peptide
Change in maximum C-peptide during MMTT (nmol/L)
Change in Fasting C-peptide
Change in Fasting C-peptide (nmol/L)
C-peptide Levels During a MMTT
C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months
Change in Body Weight
Change in body weight (kg)
Injection Site Reactions
Injection site reactions
Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.
Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)
Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations
Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal [including reflexes]). Standardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex. The outcome of the assessments was recored as "normal" or "abnormal"
GAD65A Titer
GAD65A titer (IU/ml)
Number of Clinically Significant Abnormal Results in Vital Signs
Vital signs (blood pressure) (mmHg)
Change in Quality of Life (QoL)
Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead.
Change in Body Mass Index (BMI)
Change in BMI (kg/m2)

Full Information

First Posted
November 1, 2017
Last Updated
April 11, 2022
Sponsor
Diamyd Medical AB
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1. Study Identification

Unique Protocol Identification Number
NCT03345004
Brief Title
Diamyd Administered Into Lymph Nodes in Combination With Vitamin D in Type 1 Diabetes
Official Title
A Phase IIb, 2-Arm, Randomized, Double-blind, Placebo-Controlled, Multicentre Study to Optimize Diamyd Therapy Administered Into Lymph Nodes Combined With Oral Vitamin D to Investigate the Impact on the Progression of Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2017 (Actual)
Primary Completion Date
July 13, 2020 (Actual)
Study Completion Date
April 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diamyd Medical AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Autoimmune Diseases, Metabolic Disease, Glucose Metabolism Disorders, Immune System Diseases, Endocrine System Diseases, Juvenile Diabetes, Insulin Dependent Diabetes, Autoimmune Diabetes, Vitamin D, Physiological Effects of Drugs
Keywords
Diamyd, Diabetes, Juvenile Diabetes, Diabetes Type 1, Type 1 Diabetes, Autoimmune Diabetes, Insulin Dependent Diabetes, Type 1 Diabetes Mellitus, rhGAD65, GAD65, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism Disorders, Metabolic Diseases, Vitamin D, Vitamins, Micronutrients, Cholecalciferol, Ergocalciferols

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The study is a 2-arm, randomized, double-blind, placebo-controlled, multicenter, clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active arm
Arm Type
Active Comparator
Arm 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)
Arm Title
Placebo arm
Arm Type
Placebo Comparator
Arm 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)
Intervention Type
Biological
Intervention Name(s)
Diamyd
Other Intervention Name(s)
GAD-alum
Intervention Description
Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD65)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
Oil suspension of Vitamin D
Intervention Type
Biological
Intervention Name(s)
Placebo for Diamyd
Intervention Description
Alhydrogel® only
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo for Vitamin D
Intervention Description
Placebo oil suspension for Vitamin D
Primary Outcome Measure Information:
Title
Change in Stimulated C-peptide During a MMTT
Description
Change in C-peptide between Baseline and 15 Months. C-peptide was measured by Area Under the Curve [AUC] at 0-120 min during a Mixed Meal Tolerance Test (MMTT) and divided by 120 min. The results are given as the ratio (back-transformed from log-scale) between 15 Months and Baseline as predicted by the MMRM (Mixed Model Repeated Measures) model.
Time Frame
Baseline and 15 months
Secondary Outcome Measure Information:
Title
Change in IDAA1c
Description
Change in insulin-dose-adjusted HbA1c (IDAA1c)
Time Frame
Baseline and 15 months
Title
Change in HbA1c
Description
Change in HbA1c (mmol/mol)
Time Frame
Baseline and 15 months
Title
Change in Insulin Consumption
Description
Change in daily exogenous insulin consumption (IU)
Time Frame
Baseline and 15 months
Title
Change in Glycemic Variability/Fluctuations
Description
Change in glycemic variability/fluctuations (evaluated from data from continuous glucose monitoring FreeStyle LibrePro, FGM) over 14 day period.
Time Frame
Screening and 15 months
Title
Percentage of Patients With IDAA1c ≤ 9
Description
Percentage of patients with IDAA1c ≤ 9
Time Frame
15 months
Title
Stimulated Maximum C-peptide Above 0.2 Nmol/L
Description
Percentage of patients with a stimulated maximum C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Time Frame
15 months
Title
Stimulated C-peptide Above 0.2 Nmol/L at 90 Min
Description
Percentage of patients with a stimulated 90min C-peptide level above 0.2 nmol/L (0.6 ng/ml)
Time Frame
15 months
Title
Number of Hypoglycemias
Description
Number of self-reported episodes of severe hypoglycemia (Severe hypoglycemia defined as needing help from others and/or seizures and/or unconscious) (counts)
Time Frame
Baseline and 15 months
Title
Number of Patients Having at Least 1 Severe Hypoglycemic Event
Description
Number of patients having at least 1 severe hypoglycemic event (counts)
Time Frame
Baseline and 15 months
Title
Change in Maximum C-peptide
Description
Change in maximum C-peptide during MMTT (nmol/L)
Time Frame
Baseline and 15 months
Title
Change in Fasting C-peptide
Description
Change in Fasting C-peptide (nmol/L)
Time Frame
Baseline and 15 months
Title
C-peptide Levels During a MMTT
Description
C-peptide measured at 30, 60, 90, and 120 minutes during MMTT (nmol/L) at 15 months
Time Frame
15 months
Title
Change in Body Weight
Description
Change in body weight (kg)
Time Frame
Baseline and 15 months
Title
Injection Site Reactions
Description
Injection site reactions
Time Frame
15 months
Title
Number of Clinically Significant Abnormal Results From Laboratory Measurements (Haematology and Clinical Chemistry) and Urinalysis.
Description
Number of clinically significant abnormal results from laboratory measurements (haematology and clinical chemistry) and urinalysis. (counts)
Time Frame
15 months
Title
Number of Clinically Significant Abnormal Results From Physical and Neurological Examinations
Description
Physical examination (general appearance including skin, mouth, throat, cardiovascular, abdomen, lymphatic glands, and neurological/musculoskeletal [including reflexes]). Standardised clinical neurological examination including extremity reflexes, Romberg, Walk on a line, 2 meters, Standing on 1 leg, left and right, 15 seconds per leg, Finger-nose, Mimic, Babinski reflex. The outcome of the assessments was recored as "normal" or "abnormal"
Time Frame
15 months
Title
GAD65A Titer
Description
GAD65A titer (IU/ml)
Time Frame
Baseline and 15 months
Title
Number of Clinically Significant Abnormal Results in Vital Signs
Description
Vital signs (blood pressure) (mmHg)
Time Frame
15 months
Title
Change in Quality of Life (QoL)
Description
Change in QoL as measured by the standardised measure of health questionnaire EQ-5D-5L between baseline and Month 15. The EQ-5D-5L is based on 5 questions rated at 5 levels indicating from no problem (level 1) to extreme problems (level 5) regarding current state of mobility, self-care, activity, pain and anxiety. The outcome is presented as a weighted index value, where 1 is the best possible health and 0 represents being dead.
Time Frame
Baseline and 15 months
Title
Change in Body Mass Index (BMI)
Description
Change in BMI (kg/m2)
Time Frame
Baseline and 15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnny Ludvigsson, MD, Prof
Organizational Affiliation
Universitetssjukhuset i Linköping
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Centre, Institute of Clinical and Experimental Medicine
City
Praha
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Department of Paediatrics, University Hospital Motol
City
Praha
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Diabeter Rotterdam
City
Rotterdam
ZIP/Postal Code
3011 TA
Country
Netherlands
Facility Name
Adult and Pediatrics Endocrinology and Diabetology, Hospital Universitario Cruces
City
Barakaldo
ZIP/Postal Code
48903
Country
Spain
Facility Name
Adult Endocrinology and Diabetology, Hospital vall D' Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Pediatrics Endocrinology and Diabetology, Hospital Vall D'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Adult Endocrinology and Diabetology, Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Adult Endocrinology and Diabetology, Hospital Carlos Haya
City
Málaga
ZIP/Postal Code
29009
Country
Spain
Facility Name
Pediatrics Endocrinology and Diabetology, Hospital Materno-Ifantil
City
Málaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Adult Endocrinology and Diabetology, Hospital Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Pediatrics Endocrinology and Diabetology, Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Adult and Pediatrics Endocrinology and Diabetology, Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Barn- och Ungdomskliniken, Universitetssjukhuset
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Endokrinmedicinska kliniken. Universitetssjukhuset
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Barn-och Ungdomsmedicinmottagningen and Endokrinmottagningen, Skånes Universitetssjukhus
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Barn- och ungdomskliniken, Uddevalla Sjukhus
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Diabetesmottagningen, Uddevalla Sjukhus
City
Uddevalla
ZIP/Postal Code
45180
Country
Sweden
Facility Name
Barnmottagningen, Norrlands Universitetssjukhus
City
Umeå
ZIP/Postal Code
901 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
28199812
Citation
Ludvigsson J, Wahlberg J, Casas R. Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Feb 16;376(7):697-699. doi: 10.1056/NEJMc1616343. No abstract available. Erratum In: N Engl J Med. 2017 Jul 27;377(4):405.
Results Reference
background
PubMed Identifier
28745988
Citation
Ludvigsson J, Tavira B, Casas R. More on Intralymphatic Injection of Autoantigen in Type 1 Diabetes. N Engl J Med. 2017 Jul 27;377(4):403-5. doi: 10.1056/NEJMc1703468. No abstract available.
Results Reference
background
PubMed Identifier
35665810
Citation
Nowak C, Lind M, Sumnik Z, Pelikanova T, Nattero-Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Hanas R, Hernandez C, Clemente-Leon M, Gomez-Gila A, Ferrer Lozano M, Sas T, Pruhova S, Dietrich F, Puente-Marin S, Hannelius U, Casas R, Ludvigsson J. Intralymphatic GAD-Alum (Diamyd(R)) Improves Glycemic Control in Type 1 Diabetes With HLA DR3-DQ2. J Clin Endocrinol Metab. 2022 Aug 18;107(9):2644-2651. doi: 10.1210/clinem/dgac343.
Results Reference
derived
PubMed Identifier
34021020
Citation
Ludvigsson J, Sumnik Z, Pelikanova T, Nattero Chavez L, Lundberg E, Rica I, Martinez-Brocca MA, Ruiz de Adana M, Wahlberg J, Katsarou A, Hanas R, Hernandez C, Clemente Leon M, Gomez-Gila A, Lind M, Lozano MF, Sas T, Samuelsson U, Pruhova S, Dietrich F, Puente Marin S, Nordlund A, Hannelius U, Casas R. Intralymphatic Glutamic Acid Decarboxylase With Vitamin D Supplementation in Recent-Onset Type 1 Diabetes: A Double-Blind, Randomized, Placebo-Controlled Phase IIb Trial. Diabetes Care. 2021 Jul;44(7):1604-1612. doi: 10.2337/dc21-0318. Epub 2021 May 21.
Results Reference
derived
Links:
URL
http://www.diagnode-2.com
Description
Information regarding the clinical trial

Learn more about this trial

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

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